Details for New Drug Application (NDA): 091425
✉ Email this page to a colleague
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 091425
Tradename: | LEVONORGESTREL AND ETHINYL ESTRADIOL |
Applicant: | Lupin Ltd |
Ingredient: | ethinyl estradiol; levonorgestrel |
Patents: | 0 |
Suppliers and Packaging for NDA: 091425
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVONORGESTREL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 091425 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-854 | 68180-854-73 | 3 BLISTER PACK in 1 CARTON (68180-854-73) / 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: | Jan 18, 2013 | TE: | AB1 | RLD: | No |
Complete Access Available with Subscription