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Details for New Drug Application (NDA): 077246

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NDA 077246 describes DANAZOL, which is a drug marketed by Lannett, Am Therap, and Barr, 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 NDA: 077246

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

Pharmacology for NDA: 077246

Mechanism of ActionAndrogen Receptor Agonists

Suppliers and Packaging for NDA: 077246

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 077246 ANDA Lannett Company, Inc. 0527-1369 0527-1369-01 100 CAPSULE in 1 BOTTLE (0527-1369-01)
CAPSULE;ORAL 077246 ANDA Lannett Company, Inc. 0527-1369 0527-1369-06 60 CAPSULE in 1 BOTTLE (0527-1369-06)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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