Details for New Drug Application (NDA): 205278
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NDA 205278 describes NORETHINDRONE ACETATE, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Barr, Glenmark Pharms Ltd, Novast Labs, Xiromed, Barr Labs Inc, Dr Reddys Labs Sa, and Apotex, and is included in twenty-nine NDAs. It is available from seven suppliers. Additional details are available on the NORETHINDRONE ACETATE profile page.
The generic ingredient in NORETHINDRONE ACETATE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
The generic ingredient in NORETHINDRONE ACETATE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 205278
| Tradename: | NORETHINDRONE ACETATE |
| Applicant: | Xiromed |
| Ingredient: | norethindrone acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205278
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NORETHINDRONE ACETATE | norethindrone acetate | TABLET;ORAL | 205278 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7291 | 0378-7291-89 | 50 TABLET in 1 BOTTLE (0378-7291-89) |
| NORETHINDRONE ACETATE | norethindrone acetate | TABLET;ORAL | 205278 | ANDA | Xiromed LLC | 70700-326 | 70700-326-50 | 50 TABLET in 1 BOTTLE (70700-326-50) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Nov 10, 2016 | TE: | AB | RLD: | No | ||||
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