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Details for New Drug Application (NDA): 071044
The generic ingredient in NORETHINDRONE AND ETHINYL ESTRADIOL (10/11) is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 071044
Tradename: | NORETHINDRONE AND ETHINYL ESTRADIOL (10/11) |
Applicant: | Watson Labs Teva |
Ingredient: | ethinyl estradiol; norethindrone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 071044
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11) | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 071044 | ANDA | Actavis Pharma, Inc. | 52544-554 | N | 52544-554-28 |
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11) | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 071044 | ANDA | Actavis Pharma, Inc. | 52544-554 | N | 52544-554-31 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG,0.035MG;0.5MG,1MG | ||||
Approval Date: | Apr 1, 1988 | TE: | RLD: | No |
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