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Details for New Drug Application (NDA): 201108
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 201108
Tradename: | LEVONORGESTREL AND ETHINYL ESTRADIOL |
Applicant: | Amneal Pharms |
Ingredient: | ethinyl estradiol; levonorgestrel |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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 | E | 51660-572-86 |
LEVONORGESTREL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 201108 | ANDA | Amneal Pharmaceuticals LLC | 60219-1531 | N | 60219-1531-6 |
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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