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Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090538

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NDA 090538 describes BRIELLYN, which is a drug marketed by Glenmark Generics and is included in one NDA. It is available from one supplier. Additional details are available on the BRIELLYN profile page.

The generic ingredient in BRIELLYN is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 090538
Applicant:Glenmark Generics
Ingredient:ethinyl estradiol; norethindrone
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 090538
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BRIELLYN ethinyl estradiol; norethindrone TABLET;ORAL-28 090538 ANDA Glenmark Pharmaceuticals Inc., USA 68462-316 N 68462-316-29

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;0.4MG
Approval Date:Mar 22, 2011TE:ABRLD:No

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