Details for New Drug Application (NDA): 077246

NDA 077246 describes DANAZOL, which is a drug marketed by Am Therap, Barr, and Lannett Co Inc, 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 Co Inc
Ingredient:	danazol
Patents:	0

Pharmacology for NDA: 077246

Mechanism of Action

Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 077246

Estrogen Antagonists

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	0527-1369-01	100 CAPSULE in 1 BOTTLE (0527-1369-01)
DANAZOL	danazol	CAPSULE;ORAL	077246	ANDA	Lannett Company, Inc.	0527-1369	0527-1369-06	60 CAPSULE in 1 BOTTLE (0527-1369-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Sep 28, 2005	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Apr 19, 2007	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Apr 19, 2007	TE:	AB	RLD:	No

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