Details for New Drug Application (NDA): 200275
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NDA 200275 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 200275
| Tradename: | NORETHINDRONE ACETATE |
| Applicant: | Amneal Pharms |
| Ingredient: | norethindrone acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 200275
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NORETHINDRONE ACETATE | norethindrone acetate | TABLET;ORAL | 200275 | ANDA | AvKARE | 42291-650 | 42291-650-90 | 90 TABLET in 1 BOTTLE (42291-650-90) |
| NORETHINDRONE ACETATE | norethindrone acetate | TABLET;ORAL | 200275 | ANDA | Amneal Pharmaceuticals LLC | 65162-475 | 65162-475-03 | 30 TABLET in 1 BOTTLE (65162-475-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jul 30, 2012 | TE: | AB | RLD: | No | ||||
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