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Last Updated: May 11, 2021

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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 Am Therap, Barr, and Lannett Co Inc, and is included in three NDAs. It is available from three 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. Three suppliers are listed for this compound. Additional details are available on the danazol profile page.
Summary for 074582
Formulation / Manufacturing:see details
Pharmacology for NDA: 074582
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 074582
Suppliers and Packaging for NDA: 074582
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DANAZOL danazol CAPSULE;ORAL 074582 ANDA Teva Pharmaceuticals USA, Inc. 0555-0633 0555-0633-02 100 CAPSULE in 1 BOTTLE (0555-0633-02)
DANAZOL danazol CAPSULE;ORAL 074582 ANDA Teva Pharmaceuticals USA, Inc. 0555-0634 0555-0634-02 100 CAPSULE in 1 BOTTLE (0555-0634-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Aug 9, 1996TE:ABRLD:No

Profile for product number 002

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

Profile for product number 003

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

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