Details for New Drug Application (NDA): 091663
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NDA 091663 describes LEVONORGESTREL AND ETHINYL ESTRADIOL, which is a drug marketed by Amneal Pharms, Glenmark Pharms Ltd, Lupin Ltd, Watson Labs, Xiromed, Barr, Dr Reddys Labs Sa, Hetero Labs, and Naari Pte Ltd, and is included in twenty-nine NDAs. It is available from eleven suppliers. Additional details are available on the LEVONORGESTREL AND ETHINYL ESTRADIOL profile page.
The generic ingredient in LEVONORGESTREL AND ETHINYL ESTRADIOL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
The generic ingredient in LEVONORGESTREL AND ETHINYL ESTRADIOL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 091663
| Tradename: | LEVONORGESTREL AND ETHINYL ESTRADIOL |
| Applicant: | Xiromed |
| Ingredient: | ethinyl estradiol; levonorgestrel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091663
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVONORGESTREL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 091663 | ANDA | Mylan Pharmaceuticals Inc. | 0378-6550 | 0378-6550-53 | 3 POUCH in 1 CARTON (0378-6550-53) / 1 BLISTER PACK in 1 POUCH (0378-6550-85) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.03MG;0.15MG | ||||
| Approval Date: | Dec 21, 2012 | TE: | AB | RLD: | No | ||||
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