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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 090938


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NDA 090938 describes NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, which is a drug marketed by Amneal Pharms, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Apotex, Barr Labs Inc, Mylan Labs Ltd, and Xiromed, and is included in eleven NDAs. It is available from five suppliers. Additional details are available on the NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE profile page.

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-four suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Suppliers and Packaging for NDA: 090938
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 090938 ANDA Teva Pharmaceuticals USA, Inc. 0093-5328 0093-5328-62 3 POUCH in 1 CARTON (0093-5328-62) / 1 BLISTER PACK in 1 POUCH (0093-5328-28) / 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.02MG;1MG
Approval Date:Dec 1, 2014TE:ABRLD:No

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