Details for New Drug Application (NDA): 078324
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NDA 078324 describes ESTRADIOL AND NORETHINDRONE ACETATE, which is a drug marketed by Barr, Breckenridge Pharm, Naari Pte Ltd, Novast Labs, Teva Pharms Usa, and Xiromed, and is included in six NDAs. It is available from five suppliers. Additional details are available on the ESTRADIOL AND NORETHINDRONE ACETATE profile page.
The generic ingredient in ESTRADIOL AND NORETHINDRONE ACETATE is estradiol; norethindrone acetate. There are seventy-five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.
The generic ingredient in ESTRADIOL AND NORETHINDRONE ACETATE is estradiol; norethindrone acetate. There are seventy-five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.
Summary for 078324
| Tradename: | ESTRADIOL AND NORETHINDRONE ACETATE |
| Applicant: | Breckenridge Pharm |
| Ingredient: | estradiol; norethindrone acetate |
| Patents: | 0 |
Pharmacology for NDA: 078324
| Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 078324
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESTRADIOL AND NORETHINDRONE ACETATE | estradiol; norethindrone acetate | TABLET;ORAL | 078324 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-474 | 51991-474-28 | 1 BLISTER PACK in 1 CARTON (51991-474-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK |
| ESTRADIOL AND NORETHINDRONE ACETATE | estradiol; norethindrone acetate | TABLET;ORAL | 078324 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-623 | 51991-623-28 | 1 BLISTER PACK in 1 CARTON (51991-623-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG;0.5MG | ||||
| Approval Date: | Apr 17, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG;0.1MG | ||||
| Approval Date: | Jun 9, 2011 | TE: | AB | RLD: | No | ||||
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