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Details for New Drug Application (NDA): 071044
NDA 071044 describes NORETHINDRONE AND ETHINYL ESTRADIOL (10/11), which is a drug marketed by Watson Labs and Watson Labs Teva and is included in two NDAs. It is available from one supplier. Additional details are available on the NORETHINDRONE AND ETHINYL ESTRADIOL (10/11) profile page.
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.
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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