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Details for New Drug Application (NDA): 201108
NDA 201108 describes LEVONORGESTREL AND ETHINYL ESTRADIOL, which is a drug marketed by Amneal Pharms, Glenmark Generics, Glenmark Pharms Ltd, Lupin Ltd, Mylan Labs Ltd, Watson Labs, Barr, Mayne Pharma, and Labs Leon Farma, and is included in twenty-five 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-six 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-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 201108
| Tradename: | LEVONORGESTREL AND ETHINYL ESTRADIOL |
| Applicant: | Amneal Pharms |
| Ingredient: | ethinyl estradiol; levonorgestrel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 201108
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVONORGESTREL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 201108 | ANDA | OHM LABORATORIES INC. | 51660-572 | 51660-572-86 | 1 KIT in 1 CARTON (51660-572-86) * 7 TABLET, FILM COATED in 1 BLISTER PACK * 21 TABLET, FILM COATED in 1 BLISTER PACK |
| LEVONORGESTREL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 201108 | ANDA | Amneal Pharmaceuticals LLC | 60219-1531 | 60219-1531-6 | 1 BLISTER PACK in 1 CARTON (60219-1531-6) > 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.02MG;0.1MG | ||||
| Approval Date: | Feb 5, 2014 | TE: | AB1 | RLD: | No | ||||
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