Details for New Drug Application (NDA): 091452
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The generic ingredient in MARLISSA 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 091452
Tradename: | MARLISSA |
Applicant: | Glenmark Generics |
Ingredient: | ethinyl estradiol; levonorgestrel |
Patents: | 0 |
Suppliers and Packaging for NDA: 091452
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MARLISSA | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 091452 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-388 | 68462-388-29 | 3 BLISTER PACK in 1 CARTON (68462-388-29) / 1 KIT in 1 BLISTER PACK (68462-388-84) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.03MG;0.15MG | ||||
Approval Date: | Feb 29, 2012 | TE: | AB | RLD: | No |
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