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Last Updated: June 19, 2021

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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 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 077246
Applicant:Lannett Co Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 077246
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 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: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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