Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074582
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DANAZOL DANAZOL 200MG CAPSULE;ORAL Prescription AB No Yes
DANAZOL DANAZOL 100MG CAPSULE;ORAL Prescription AB No No
DANAZOL DANAZOL 50MG CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/09/1996 ORIG-1 Approval Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/96/074582_danazol_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/22/2018 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

03/19/2012 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

03/28/2001 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

12/21/1999 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

05/20/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/26/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/26/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/26/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/29/1998 SUPPL-2 Labeling

Label is not available on this site.

05/29/1998 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.

DANAZOL

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DANAZOL DANAZOL 200MG CAPSULE;ORAL Prescription No AB 074582 BARR
DANAZOL DANAZOL 200MG CAPSULE;ORAL Prescription No AB 077246 LANNETT CO INC

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DANAZOL DANAZOL 100MG CAPSULE;ORAL Prescription No AB 074582 BARR
DANAZOL DANAZOL 100MG CAPSULE;ORAL Prescription No AB 078214 LANNETT
DANAZOL DANAZOL 100MG CAPSULE;ORAL Prescription No AB 077246 LANNETT CO INC

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DANAZOL DANAZOL 50MG CAPSULE;ORAL Prescription No AB 074582 BARR
DANAZOL DANAZOL 50MG CAPSULE;ORAL Prescription No AB 078214 LANNETT
DANAZOL DANAZOL 50MG CAPSULE;ORAL Prescription No AB 077246 LANNETT CO INC

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