Details for New Drug Application (NDA): 207514
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The generic ingredient in NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 207514
Tradename: | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE |
Applicant: | Amneal Pharms |
Ingredient: | ethinyl estradiol; norethindrone acetate |
Patents: | 0 |
Suppliers and Packaging for NDA: 207514
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 207514 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1031 | 60219-1031-7 | 3 BLISTER PACK in 1 CARTON (60219-1031-7) / 1 KIT in 1 BLISTER PACK (60219-1031-6) |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 207514 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1031 | 69238-1031-7 | 3 BLISTER PACK in 1 CARTON (69238-1031-7) / 1 KIT in 1 BLISTER PACK (69238-1031-6) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.02MG;1MG | ||||
Approval Date: | Sep 11, 2017 | TE: | RLD: | No |
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