Details for New Drug Application (NDA): 076221
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NDA 076221 describes NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, which is a drug marketed by Barr Labs Inc, Glenmark Generics, Mylan Labs Ltd, Glenmark Pharms Ltd, Dr Reddys Labs Sa, Mylan, Amneal Pharms, Apotex, and Xiromed, and is included in twenty-three NDAs. It is available from four suppliers. Additional details are available on the NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL profile page.
The generic ingredient in NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 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.
The generic ingredient in NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 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.
Summary for 076221
| Tradename: | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL |
| Applicant: | Barr Labs Inc |
| Ingredient: | ethinyl estradiol; norethindrone acetate |
| Patents: | 0 |
Pharmacology for NDA: 076221
| Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 076221
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 076221 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-3122 | 0093-3122-42 | 5 BLISTER PACK in 1 CARTON (0093-3122-42) / 28 TABLET in 1 BLISTER PACK (0093-3122-28) |
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 076221 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-3122 | 0093-3122-98 | 90 TABLET in 1 BOTTLE (0093-3122-98) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.005MG;1MG | ||||
| Approval Date: | Nov 6, 2009 | TE: | AB | RLD: | No | ||||
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