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Last Updated: February 20, 2020

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. One supplier is listed for this compound. Additional details are available on the methyltestosterone profile page.
Summary for 080767
Applicant:Impax Labs
Formulation / Manufacturing:see details
Pharmacology for NDA: 080767
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 Amneal Pharmaceuticals of New York LLC 0115-7037 0115-7037-01 100 TABLET in 1 BOTTLE (0115-7037-01)

Profile 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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