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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Argus Health
Boehringer Ingelheim

Generated: July 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075671

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NDA 075671 describes MEGESTROL ACETATE, which is a drug marketed by Apotex Inc, Wockhardt, Barr, Par Pharm, Twi Pharms Inc, Teva, Usl Pharma, West-ward Pharms Int, Hi-tech Pharmacal, and Teva Pharms, and is included in fourteen NDAs. It is available from twenty-three suppliers. Additional details are available on the MEGESTROL ACETATE profile page.

The generic ingredient in MEGESTROL ACETATE is megestrol acetate. There are eighteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.

Summary for NDA: 075671

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 075671

Ingredient-typeProgesterone Congeners

Suppliers and Packaging for NDA: 075671

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
megestrol acetate
SUSPENSION;ORAL 075671 ANDA Atlantic Biologicals Corps 17856-0907 17856-0907-2 20 mL in 1 CUP (17856-0907-2)
megestrol acetate
SUSPENSION;ORAL 075671 ANDA Atlantic Biologicals Corps 17856-0907 17856-0907-3 10 mL in 1 CUP (17856-0907-3)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength40MG/ML
Approval Date:Jul 25, 2001TE:ABRLD:No

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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
Harvard Business School
US Department of Justice
Federal Trade Commission
Johnson and Johnson
US Army
Daiichi Sankyo

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