Details for New Drug Application (NDA): 078833
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NDA 078833 describes DROSPIRENONE AND ETHINYL ESTRADIOL, which is a drug marketed by Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Watson Labs, Xiromed, Apotex, Dr Reddys Labs Sa, Lupin Ltd, and Naari Pte Ltd, and is included in sixteen NDAs. It is available from ten suppliers. Additional details are available on the DROSPIRENONE AND ETHINYL ESTRADIOL profile page.
The generic ingredient in DROSPIRENONE AND ETHINYL ESTRADIOL is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.
The generic ingredient in DROSPIRENONE AND ETHINYL ESTRADIOL is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.
Summary for 078833
| Tradename: | DROSPIRENONE AND ETHINYL ESTRADIOL |
| Applicant: | Watson Labs |
| Ingredient: | drospirenone; ethinyl estradiol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078833
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL | 078833 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-4000 | 0093-4000-62 | 3 BLISTER PACK in 1 CARTON (0093-4000-62) / 1 KIT in 1 BLISTER PACK (0093-4000-28) * 24 TABLET in 1 BLISTER PACK (0093-3634-11) * 4 TABLET in 1 BLISTER PACK (0093-3622-22) |
| DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL | 078833 | ANDA | Teva Pharmaceuticals, Inc. | 0480-4000 | 0480-4000-62 | 3 BLISTER PACK in 1 CARTON (0480-4000-62) / 1 KIT in 1 BLISTER PACK (0480-4000-28) * 24 TABLET in 1 BLISTER PACK (0480-3629-11) * 4 TABLET in 1 BLISTER PACK (0480-7892-22) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG;0.02MG | ||||
| Approval Date: | Nov 28, 2011 | TE: | AB | RLD: | No | ||||
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