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Generated: April 19, 2019

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Details for New Drug Application (NDA): 091636

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NDA 091636 describes ALYACEN 7/7/7, which is a drug marketed by Glenmark Generics and is included in one NDA. It is available from three suppliers. Additional details are available on the ALYACEN 7/7/7 profile page.

The generic ingredient in ALYACEN 7/7/7 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 091636
Tradename:ALYACEN 7/7/7
Applicant:Glenmark Generics
Ingredient:ethinyl estradiol; norethindrone
Suppliers and Packaging for NDA: 091636
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALYACEN 7/7/7 ethinyl estradiol; norethindrone TABLET;ORAL-28 091636 ANDA A-S Medication Solutions 50090-1478 50090-1478-0 1 KIT in 1 KIT (50090-1478-0)
ALYACEN 7/7/7 ethinyl estradiol; norethindrone TABLET;ORAL-28 091636 ANDA RPK Pharmaceuticals, Inc. 53002-1734 53002-1734-1 1 BLISTER PACK in 1 PACKAGE (53002-1734-1) > 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
Approval Date:Jan 19, 2012TE:ABRLD:No

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