Details for New Drug Application (NDA): 214292
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NDA 214292 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, 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-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate 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-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 214292
| Tradename: | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE |
| Applicant: | Amneal Pharms |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 214292
| 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 | CAPSULE;ORAL | 214292 | ANDA | Amneal Pharmaceuticals LLC | 65162-558 | 65162-558-15 | 5 CARTON in 1 TRAY (65162-558-15) / 1 BLISTER PACK in 1 CARTON (65162-558-58) / 1 KIT in 1 BLISTER PACK |
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ethinyl estradiol; norethindrone acetate | CAPSULE;ORAL | 214292 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1686 | 69238-1686-3 | 5 CARTON in 1 TRAY (69238-1686-3) / 1 BLISTER PACK in 1 CARTON (69238-1686-6) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 0.02MG;1MG | ||||
| Approval Date: | Jul 20, 2021 | TE: | RLD: | No | |||||
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