Minivelle

Name: Minivelle

Side effects

The following serious adverse reactions are discussed elsewhere in labeling:

  • Cardiovascular Disorders [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
  • Endometrial Cancer [see BOXED WARNING, WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

There were no clinical trials conducted with MINIVELLE. MINIVELLE is bioequivalent to Vivelle®. The following adverse reactions are reported with Vivelle:

Table 1: Summary of Most Frequently Reported Adverse Reactions (Vivelle versus Placebo) Regardless of Relationship Reported at a Frequency > 5 Percent

  Vivelle 0.0375 mg/day†
(N=130) N (%)
Vivelle 0.05 mg/day†
(N=103) N (%)
Vivelle 0.075 mg/day†
(N=46) N (%)
Vivelle 0.1 mg/day†
(N=132) N (%)
Placebo
(N=157) N (%)
Gastrointestinal disorders
Constipation 5 (3.8) 4 (3.9) 3 (6.5) 2 (1.5) 4 (2.5)
Dyspepsia 12 (9.2) 3 (2.9) 2 (4.3) 0 10 (6.4)
Nausea 8 (6.2) 4 (3.9) 0 7(5.3) 5 (3.2)
General disorders and administration site conditions***
Influenza-like illness 6 (4.6) 8 (7.8) 0 3 (2.3) 10 (6.4)
Pain NOS* 8 (6.2) 0 2 (4.3) 7 (5.3) 7(4.5)
Infections and infestations
Influenza 4 (3.1) 6 (5.8) 0 10 (7.6) 14 (8.9)
Nasopharyngitis 16 (12.3) 10 (9.7) 9 (19.6) 11 (8.3) 24 (15.3)
Sinusitis NOS* 17 (13.1) 13 (12.6) 3 (6.5) 7(5.3) 16 (10.2)
Upper respiratory tract infection NoS* 8 (6.2) 11 (10.7) 4 (8.7) 6 (4.5) 9(5.7)
Investigations
Weight increased 5 (3.8) 2 (1.9) 2 (4.3) 0 3 (1.9)
Musculoskeletal and connective tissue disorders
Arthralgia 11 (8.5) 4 (3.9) 2 (4.3) 5 (3.8) 9 (5.7)
Back pain 10 (7.7) 9 (8.7) 4 (8.7) 14 (10.6) 10 (6.4)
Neck pain 4 (3.1) 4 (3.9) 0 6 (4.5) 2 (1.3)
Pain in limb 10 (7.7) 7(6.8) 2 (4.3) 6 (4.5) 9 (5.7)
Nervous system disorders
Headache NOS* 35 (26.9) 32 (31.1) 23 (50.0) 34 (25.8) 37 (23.6)
Sinus headache 12 (9.2) 5 (4.9) 5 (10.9) 2 (1.5) 8 (5.1)
Psychiatric disorders
Anxiety NEC** 5 (3.8) 0 0 2 (1.5) 4 (2.5)
Depression 4 (3.1) 7(6.8) 0 4 (3.0) 6 (3.8)
Insomnia 6 (4.6) 4 (3.9) 2 (4.3) 2 (1.5) 9(5.7)
Reproductive system and breast disorders
Breast tenderness 10 (7.7) 8 (7.8) 3 (6.5) 17 (12.9) 0
Dysmenorrhea 0 0 3 (6.5) 0 0
Intermenstrual bleeding 9 (6.9) 6 (5.8) 0 14 (10.6) 7(4.5)
Respiratory, thoracic and mediastinal disorders
Sinus congestion 4 (3.1) 3 (2.9) 3 (6.5) 6 (4.5) 7(4.5)
Vascular disorders
Hot flushes NOS* 0 3 (2.9) 0 0 6 (3.8)
Hypertension NOS* 0 3 (2.9) 0 0 2 (1.3)
† Represents milligrams of estradiol delivered daily by each system
*NOS represents not otherwise specified
**NEC represents not elsewhere classified
***Application site erythema and application site irritation were observed in 3.2% or less of patients across treatment groups.

During the clinical pharmacology studies with MINIVELLE, 35 percent or less of subjects experienced barely perceptible erythema. No transdermal systems were removed due to irritation. Three subjects (2.2 percent) reported mild discomfort while wearing MINIVELLE (N=136).

Read the entire FDA prescribing information for Minivelle (Estradiol Transdermal System)

Read More »

Uses of Minivelle

Minivelle is a prescription medication used to treat symptoms of menopause including hot flashes. It is also used to treat prevent osteoporosis in women after menopause. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Minivelle Drug Class

Minivelle is part of the drug class:

  • Natural and semisynthetic estrogens, plain

Side Effects of Minivelle

Serious side effects have been reported with Minivelle. See the “Minivelle Precautions” section.

Common side effects of Minivelle include the following:

  • headache
  • breast pain or tenderness
  • back pain
  • irregular vaginal bleeding or spotting
  • stomach or abdominal cramps, bloating
  • nausea and vomiting
  • hair loss
  • fluid retention
  • vaginal yeast infection
  • redness and/or irritation at patch placement site

This is not a complete list of Minivelle side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Minivelle Precautions

Serious side effects have been reported with Minivelle including the following:

  • bulging eyes
  • yellowing of the skin or eyes
  • itching
  • loss of appetite
  • fever
  • joint pain
  • stomach tenderness, pain, or swelling
  • movements that are difficult to control
  • hives
  • rash or blisters on the skin
  • swelling, of the eyes, face, lips, tongue, throat, hands, feet, ankles, or lower legs
  • hoarseness
  • wheezing
  • difficulty breathing or swallowing

Do not use Minivelle if you:

  • are allergic to Minivelle or to any of its ingredients
  • have abnormal vaginal bleeding
  • have a known or suspected history of breast cancer
  • have a known or suspected estrogen-dependent cancer
  • currently or have a history of blood clots
  • have had a recent heart attack or stroke
  • have liver disease
  • have been diagnosed with a bleeding disorder
  • are pregnant or possibly pregnant

Minivelle Food Interactions

Grapefruit and grapefruit juice may interact with Minivelle and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Minivelle and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

Minivelle should not be used during pregnancy. There appears to be little or no increased risk of birth defects in children born to women who inadvertently used estrogens during early pregnancy. Talk to your doctor right away if you become pregnant while using Minivelle.

Minivelle Overdose

If you use too much Minivelle, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Minivelle is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Minivelle (estradiol transdermal) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • unusual vaginal bleeding;

  • swelling or tenderness in your stomach;

  • jaundice (yellowing of the skin or eyes);

  • a lump in your breast;

  • skin rash;

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs;

  • low levels of calcium in your blood--numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes; or

  • high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless.

Common side effects may include:

  • headache;

  • weight gain, bloating, stomach cramps, nausea, vomiting;

  • fluid retention (swelling, rapid weight gain);

  • thinning scalp hair;

  • redness or irritation where the patch was worn;

  • breast pain; or

  • vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Dosage Forms and Strengths

Transdermal system: 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day.

Drug Interactions

No drug interaction studies have been conducted for Minivelle.

Metabolic Interactions

In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St. John’s wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, and grapefruit juice may increase plasma concentrations of estrogens and may result in side effects.

Patient Counseling Information

See FDA-approved patient labeling (Patient Information and Instructions for Use).

Vaginal Bleeding

Inform postmenopausal women of the importance of reporting unusual vaginal bleeding to their healthcare providers as soon as possible [see Warnings and Precautions (5.2)]

Possible Serious Adverse Reactions with Estrogen–Alone Therapy

Inform postmenopausal women of possible serious adverse reactions of estrogen-alone therapy including Cardiovascular Disorders, Malignant Neoplasms, and Probable Dementia [see Warning and Precautions (5.1,5.2,5.3)].

Possible Less Serious but Common Adverse Reactions with Estrogen–Alone Therapy

Inform postmenopausal women of less serious but common adverse reactions of estrogen-alone therapy such as headache, breast pain and tenderness, nausea and vomiting.

Patient Information

Minivelle (MIN-ee-vell)

(estradiol transdermal system)

Read this patient information before you start using Minivelle and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Minivelle (an estrogen hormone)?
  • Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using Minivelle. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause
  • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function)
  • Using estrogen-alone may increase your chances of getting strokes or blood clots
  • Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia
  • Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
  • Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • You and your healthcare provider should talk regularly about whether you still need treatment with Minivelle

What is Minivelle?

Minivelle is a prescription medicine patch (Transdermal System) that contains estradiol (an estrogen hormone). When applied to the skin as directed below, Minivelle releases estrogen through the skin into the bloodstream.

What is Minivelle® used for?

THE Minivelle patch is used after menopause to:

  • Reduce moderate to severe hot flashes
    Estrogens are hormones made by a woman’s ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes the “change of life” or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes “surgical menopause.”
    When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest or sudden strong feelings of heat and sweating (“hot flashes” or “hot flushes”). In some women, the symptoms are mild and they will not need treatment with estrogen therapy. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether or not you still need treatment with Minivelle.
  • Help reduce your chances of getting osteoporosis (thin weak bones)
    Osteoporosis from menopause is a thinning of the bones that makes them weaker and easier to break. If you use Minivelle only to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you.
    You and your healthcare provider should talk regularly about whether you should continue treatment with Minivelle.

Who should not use Minivelle?

Do not start using Minivelle if you:

  • have unusual vaginal bleeding
    Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
  • currently have or have had certain cancers
    Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use Minivelle.
  • had a stroke or heart attack
  • currently have or have had blood clots
  • currently have or have had liver problems
  • have been diagnosed with a bleeding disorder
  • are allergic to Minivelle or any of its ingredients
    See the list of ingredients in Minivelle at the end of this leaflet.
  • think you may be pregnant
    Minivelle is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not take Minivelle if the test is positive and talk to your healthcare provider.

What should I tell my healthcare provider before I use Minivelle?

Before you use Minivelle, tell your healthcare provider if you:

  • have any unusual vaginal bleeding
    Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
  • have any other medical conditions
    Your healthcare provider may need to check you more carefully if you have certain conditions such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of the face and tongue), or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
  • are going to have surgery or will be on bed rest.
    Your healthcare provider will let you know if you need to stop using Minivelle.
  • are breast feeding
    The hormone in Minivelle can pass into your breast milk.

Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Some medicines may affect how Minivelle works. Minivelle may also affect how other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use Minivelle?

For detailed instructions, see the step-by-step instructions for using Minivelle at the end of this Patient Information

  • Use Minivelle exactly as your healthcare provider tells you to use it
  • Minivelle is for skin use only
  • Change your Minivelle patch 2 times a week or every 3 to 4 days
  • Apply your Minivelle patch to a clean, dry area on your lower abdomen or buttocks. This area must be clean, dry, and free of powder, oil or lotion for your patch to stick to your skin
  • Apply your Minivelle patch to a different area of your abdomen or your buttocks each time. Do not use the same application site 2 times in the same week.
  • Do not apply Minivelle to your breasts
  • If you forget to apply a new Minivelle patch, you should apply a new patch as soon as possible.
  • You and your healthcare provider should talk regularly (every 3 to 5 months) about your dose and whether you still need treatment with Minivelle.

How to Change Minivelle

  • When changing the patch, peel off the used patch slowly from the skin
  • After removal of Minivelle, patients usually have either no adhesive residue or light adhesive residue. If any adhesive residue remains on your skin after removing the patch, allow the area to dry for 15 minutes. Then, gently rub the area with oil or lotion to remove the adhesive from your skin
  • Keep in mind, the new patch must be applied to a different area of your abdomen or buttocks. This area must be clean, dry, cool and free of powder, oil or lotion.

What are the possible side effects of Minivelle?

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious, but less common side effects include:

  • heart attack
  • stroke
  • blood clots
  • dementia
  • breast cancer
  • cancer of the lining of the uterus (womb)
  • cancer of the ovary
  • high blood pressure
  • high blood sugar
  • gallbladder disease
  • liver problems
  • changes in your thyroid hormone levels
  • enlargement of benign tumors (“fibroids”)

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

  • new breast lumps
  • unusual vaginal bleeding
  • changes in vision or speech
  • sudden new severe headaches
  • severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
  • swelling
  • rash

Less serious, but common side effects include:

  • headache
  • breast pain
  • irregular vaginal bleeding or spotting
  • stomach or abdominal cramps, bloating
  • nausea and vomiting
  • hair loss
  • fluid retention
  • vaginal yeast infection
  • redness and/or irritation at patch placement site

These are not all the possible side effects of Minivelle. For more information, ask your healthcare provider or pharmacist for advice about side effects. Tell your healthcare provider if you have any side effects that bother you or does not go away. You may report side effects to Noven at 1-800-455-8070 or to FDA at 1-800-FDA-1088.

What can I do to lower my chances of a serious side effect with Minivelle?

  • Talk with your healthcare provider regularly about whether you should continue taking Minivelle
  • If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you
    The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus (womb).
  • See your healthcare provider right away if you get vaginal bleeding while using Minivelle
  • Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else
    If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often
  • If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances of getting heart disease
    Ask your healthcare provider for ways to lower your chances of getting heart disease.

How should I store and throw away used Minivelle patches?

  • Store at room temperature 68°F to 77°F (20°C to 25°C)
  • Do not store Minivelle patches outside of their pouches. Apply immediately upon removal from the protective pouch
  • Used patches still contain estrogen. To throw away the patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place this container in the trash. Used patches should not be flushed in the toilet

KEEP Minivelle and all other medicines out of the reach of children

General information about safe and effective use of Minivelle

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Minivelle for conditions for which it was not prescribed. Do not give Minivelle to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about Minivelle. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about Minivelle that is written for health professionals.

For more information, go to www.Minivelle.com or call Noven Pharmaceuticals Inc at 1-800-455-8070.

What are the ingredients in Minivelle?

Active ingredient: estradiol

Inactive ingredients: Polyester film laminate, acrylic and silicone adhesives, oleyl alcohol, NF, povidone, USP and dipropylene glycol and a polyester release liner

Instructions for Use

Minivelle® (MIN-ee-vell)

(estradiol transdermal system)

Read this PATIENT INFORMATION before you start using Minivelle and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.

You will need the following supplies (See Figure A).


Figure A

Step 1: Pick the days you will change your patch.

  • You will need to change your patch 2 times a week or every 3 to 4 days. Use the calendar printed inside your carton to choose the 2 days you will change your patch (See Figure B).
  • Remember to change your patch on the same 2 days you marked on your calendar. If you forget to change your patch on the correct date, apply a new patch as soon as you remember, and continue to follow your original schedule


Figure B

Step 2. Remove the Minivelle patch from the pouch.

  • Remove the patch from its protective pouch by tearing at the notch (do not use scissors, See Figure C).
  • Do not remove your patch from the protective pouch until you are ready to apply it


Figure C

Step 3. Remove half of the adhesive liner (See Figure D).


Figure D

Step 4. Placing the patch on your skin.

  • Hold the part of the patch that still has the adhesive liner on it
  • Avoid touching the sticky half of the patch with your fingers
  • Apply the exposed sticky half of the patch to 1 of the areas of skin shown below (See Figures E and F).

Note:

  • Avoid the waistline, since clothing and belts may cause the patch to be rubbed off
  • Do not apply the patch to your breasts
  • Only apply the patch to skin that is clean, dry, and free of any powder, oil, or lotion
  • You should not apply the patch to injured, burned, or irritated skin, or areas with skin conditions (such as birth marks, tattoos, or that is very hairy)

Step 5: Press the patch firmly onto your skin.

  • Remove the remaining half of the adhesive liner and press the entire patch into place with the palm of your hand for 10 seconds
  • Rub the edges of the patch with your fingers to make sure that it will stick to your skin (See Figure G).


Figure G

Note:

  • Showering will not cause your patch to fall off
  • If your patch falls off reapply it. If you cannot reapply the patch, apply a new patch to another area (See Figures E and D) and continue to follow your original placement schedule
  • If you stop using your Minivelle patch or forget to apply a new patch as scheduled, you may have spotting, or bleeding, and recurrence of symptoms

Step 6: Throwing away your used patch.

  • When it is time to change your patch, remove the old patch before you apply a new patch
  • To throw away the patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place this container in the trash. Used patches should not be flushed in the toilet

This Patient Information and Instructions for Use have been approved by the U.S Food and Drug Administration.


Manufactured by:
Noven Pharmaceuticals Inc.
Miami, FL 33186

Approved 09/2014

Package Label - Principal Display Panel – 0.025mg Pouch

Package Label - Principal Display Panel – 0.025mg Sample Carton

Package Label - Principal Display Panel – 0.025mg Trade Carton

Package Label - Principal Display Panel – 0.0375mg Pouch

Package Label - Principal Display Panel – 0.0375mg Carton

Package Label - Principal Display Panel – 0.05mg Pouch

Package Label - Principal Display Panel – 0.05mg Carton

Package Label - Principal Display Panel – 0.075mg Pouch

Package Label - Principal Display Panel – 0.075mg Carton

Package Label - Principal Display Panel – 0.1mg Pouch

Package Label - Principal Display Panel – 0.1mg Carton

Minivelle 
estradiol film, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68968-6625
Route of Administration TRANSDERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 0.025 mg  in 1 d
Inactive Ingredients
Ingredient Name Strength
DIPROPYLENE GLYCOL  
OLEYL ALCOHOL  
POVIDONES  
Packaging
# Item Code Package Description
1 NDC:68968-6625-8 8 POUCH in 1 PACKET
1 NDC:68968-6625-1 1 d in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203752 12/20/2012
Minivelle 
estradiol film, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68968-6637
Route of Administration TRANSDERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 0.0375 mg  in 1 d
Inactive Ingredients
Ingredient Name Strength
DIPROPYLENE GLYCOL  
OLEYL ALCOHOL  
POVIDONE  
Packaging
# Item Code Package Description
1 NDC:68968-6637-8 8 POUCH in 1 PACKET
1 NDC:68968-6637-1 1 d in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203752 12/20/2012
Minivelle 
estradiol film, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68968-6650
Route of Administration TRANSDERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 0.05 mg  in 1 d
Inactive Ingredients
Ingredient Name Strength
DIPROPYLENE GLYCOL  
OLEYL ALCOHOL  
POVIDONE  
Packaging
# Item Code Package Description
1 NDC:68968-6650-8 8 POUCH in 1 PACKET
1 NDC:68968-6650-1 1 d in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203752 12/20/2012
Minivelle 
estradiol film, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68968-6675
Route of Administration TRANSDERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 0.075 mg  in 1 d
Inactive Ingredients
Ingredient Name Strength
DIPROPYLENE GLYCOL  
OLEYL ALCOHOL  
POVIDONE  
Packaging
# Item Code Package Description
1 NDC:68968-6675-8 8 POUCH in 1 PACKET
1 NDC:68968-6675-1 1 d in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203752 12/20/2012
Minivelle 
estradiol film, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68968-6610
Route of Administration TRANSDERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 0.10 mg  in 1 d
Inactive Ingredients
Ingredient Name Strength
DIPROPYLENE GLYCOL  
OLEYL ALCOHOL  
POVIDONE  
Packaging
# Item Code Package Description
1 NDC:68968-6610-8 8 POUCH in 1 PACKET
1 NDC:68968-6610-1 1 d in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203752 12/20/2012
Labeler - Noven Therapeutics, LLC (166888268)
Registrant - Noven Pharmaceuticals, Inc. (148585441)
Establishment
Name Address ID/FEI Operations
Noven Pharmaceuticals, Inc. 148585441 MANUFACTURE(68968-6625, 68968-6637, 68968-6650, 68968-6675, 68968-6610)
Revised: 09/2014   Noven Therapeutics, LLC
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