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Generated: July 24, 2017

DrugPatentWatch Database Preview

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. Seventeen suppliers are listed for this compound. Additional details are available on the norethindrone profile page.

Summary for NDA: 090454

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 090454

Ingredient-typeProgesterone Congeners

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

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

Cerilliant
Baxter
Julphar
Cantor Fitzgerald
Deloitte
Johnson and Johnson
Queensland Health
Federal Trade Commission
Novartis
Teva

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