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Details for New Drug Application (NDA): 074582

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NDA 074582 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: 074582

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

Pharmacology for NDA: 074582

Mechanism of ActionAndrogen Receptor Agonists

Suppliers and Packaging for NDA: 074582

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 074582 ANDA Teva Pharmaceuticals USA, Inc. 0555-0633 0555-0633-02 100 CAPSULE in 1 BOTTLE (0555-0633-02)
CAPSULE;ORAL 074582 ANDA Teva Pharmaceuticals USA, Inc. 0555-0634 0555-0634-02 100 CAPSULE in 1 BOTTLE (0555-0634-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Aug 9, 1996TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:May 29, 1998TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:May 29, 1998TE:ABRLD:No

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