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US Army
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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080767

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NDA 080767 describes METHYLTESTOSTERONE, which is a drug marketed by Heather, Impax Labs Inc, Impax Labs, Lilly, Purepac Pharm, Pvt Form, Tablicaps, Usl Pharma, Inwood Labs, Kv Pharm, Lannett, Parke Davis, Watson Labs, and West Ward, and is included in twenty-seven NDAs. It is available from one supplier. Additional details are available on the METHYLTESTOSTERONE profile page.

The generic ingredient in METHYLTESTOSTERONE is methyltestosterone. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the methyltestosterone profile page.

Summary for 080767

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 080767

Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 080767

Suppliers and Packaging for NDA: 080767

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLTESTOSTERONE methyltestosterone TABLET;ORAL 080767 ANDA Impax Generics 0115-7037 0115-7037-01 100 TABLET in 1 BOTTLE (0115-7037-01)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:BPRLD:No


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Serving leading biopharmaceutical companies globally:

Argus Health
McKinsey
Queensland Health
Merck
Cantor Fitzgerald
Express Scripts
Johnson and Johnson
AstraZeneca
Chubb
Moodys

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