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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077246

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NDA 077246 describes DANAZOL, which is a drug marketed by Am Therap, Barr, and Lannett, and is included in three NDAs. It is available from four suppliers. Additional details are available on the DANAZOL profile page.

The generic ingredient in DANAZOL is danazol. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the danazol profile page.
Summary for 077246
Tradename:DANAZOL
Applicant:Lannett
Ingredient:danazol
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 077246
Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 077246
Suppliers and Packaging for NDA: 077246
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DANAZOL danazol CAPSULE;ORAL 077246 ANDA Lannett Company, Inc. 0527-1369 N 0527-1369-01
DANAZOL danazol CAPSULE;ORAL 077246 ANDA Lannett Company, Inc. 0527-1369 N 0527-1369-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Sep 28, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Apr 19, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Apr 19, 2007TE:ABRLD:No

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