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Details for New Drug Application (NDA): 091452

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NDA 091452 describes MARLISSA, which is a drug marketed by Glenmark Generics and is included in one NDA. It is available from two suppliers. Additional details are available on the MARLISSA profile page.

The generic ingredient in MARLISSA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for NDA: 091452

Glenmark Generics
ethinyl estradiol; levonorgestrel

Suppliers and Packaging for NDA: 091452

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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)
ethinyl estradiol; levonorgestrel
TABLET;ORAL-28 091452 ANDA Preferreed Pharmaceuticals Inc. 68788-6339 68788-6339-2 1 KIT in 1 BLISTER PACK (68788-6339-2)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.03MG;0.15MG
Approval Date:Feb 29, 2012TE:ABRLD:No

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