Details for New Drug Application (NDA): 077681
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NDA 077681 describes LEVONORGESTREL AND ETHINYL ESTRADIOL, which is a drug marketed by Glenmark Pharms Ltd, Lupin Ltd, Naari Pte, Watson Labs, Xiromed, Barr, Amneal Pharms, Dr Reddys Labs Sa, and Hetero Labs, and is included in twenty-nine NDAs. It is available from eight 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-three 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-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 077681
| Tradename: | LEVONORGESTREL AND ETHINYL ESTRADIOL |
| Applicant: | Dr Reddys Labs Sa |
| Ingredient: | ethinyl estradiol; levonorgestrel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 077681
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVONORGESTREL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 077681 | ANDA | Mayne Pharma Inc. | 51862-545 | 51862-545-06 | 6 BLISTER PACK in 1 CARTON (51862-545-06) / 1 KIT in 1 BLISTER PACK (51862-545-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.02MG;0.1MG | ||||
| Approval Date: | May 31, 2006 | TE: | AB2 | RLD: | No | ||||
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