Details for New Drug Application (NDA): 078892
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The generic ingredient in NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 078892
Tradename: | NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE |
Applicant: | Amneal Pharms |
Ingredient: | ethinyl estradiol; norethindrone |
Patents: | 0 |
Suppliers and Packaging for NDA: 078892
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ethinyl estradiol; norethindrone | TABLET;ORAL | 078892 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1581 | 69238-1581-3 | 3 BLISTER PACK in 1 CARTON (69238-1581-3) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.035MG;0.4MG | ||||
Approval Date: | Sep 26, 2011 | TE: | AB | RLD: | No |
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