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Generated: March 19, 2019

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Details for New Drug Application (NDA): 090454

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NDA 090454 describes HEATHER, 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 HEATHER profile page.

The generic ingredient in HEATHER is norethindrone. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the norethindrone profile page.
Summary for 090454
Applicant:Glenmark Generics
Formulation / Manufacturing:see details
Pharmacology for NDA: 090454
Medical Subject Heading (MeSH) Categories for 090454
Suppliers and Packaging for NDA: 090454
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HEATHER norethindrone TABLET;ORAL-28 090454 ANDA Glenmark Pharmaceuticals Inc., USA 68462-303 68462-303-29 3 BLISTER PACK in 1 CARTON (68462-303-29) > 28 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.35MG
Approval Date:Apr 23, 2010TE:AB1RLD:No

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