Details for New Drug Application (NDA): 079218
✉ 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-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 079218
Tradename: | LEVONORGESTREL AND ETHINYL ESTRADIOL |
Applicant: | Watson Labs |
Ingredient: | ethinyl estradiol; levonorgestrel |
Patents: | 0 |
Pharmacology for NDA: 079218
Mechanism of Action | Estrogen Receptor Agonists |
Physiological Effect | Inhibit Ovum Fertilization |
Suppliers and Packaging for NDA: 079218
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVONORGESTREL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 079218 | ANDA | Teva Pharmaceuticals, Inc. | 0480-3472 | 0480-3472-24 | 1 POUCH in 1 CARTON (0480-3472-24) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK |
LEVONORGESTREL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 079218 | ANDA | Actavis Pharma, Inc. | 52544-295 | 52544-295-28 | 1 POUCH in 1 CARTON (52544-295-28) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.02MG;0.09MG | ||||
Approval Date: | Jun 6, 2011 | TE: | AB | RLD: | No |
Complete Access Available with Subscription