APPLICATION
ANDA074582
TYPE
ANDA
ORIGINAL APPROVAL
1996-08-09
LATEST ACTION
2018-08-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
DANAZOLPrescription
DANAZOL 50MG · CAPSULE · ORAL
DANAZOLPrescription
DANAZOL 200MG · CAPSULE · ORAL
DANAZOLPrescription
DANAZOL 100MG · CAPSULE · ORAL
Approval history
2018-08-22Labeling · Supplement 31 · standardAP
2012-03-19Labeling · Supplement 25AP
2001-03-28Manufacturing (CMC) · Supplement 9AP
1999-12-21Manufacturing (CMC) · Supplement 8AP
1999-05-20Manufacturing (CMC) · Supplement 7AP
1998-12-01Manufacturing (CMC) · Supplement 3AP
1998-10-26Manufacturing (CMC) · Supplement 6AP
1998-10-26Manufacturing (CMC) · Supplement 4AP
1998-10-26Manufacturing (CMC) · Supplement 5AP
1998-05-29Labeling · Supplement 2AP
1998-05-29Manufacturing (CMC) · Supplement 1AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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