APPLICATION
ANDA077246
TYPE
ANDA
ORIGINAL APPROVAL
2005-09-28
LATEST ACTION
2018-08-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
DANAZOLPrescription
DANAZOL 200MG · CAPSULE · ORAL
DANAZOLPrescription
DANAZOL 50MG · CAPSULE · ORAL
DANAZOLPrescription
DANAZOL 100MG · CAPSULE · ORAL
Approval history
2018-08-22Labeling · Supplement 14 · standardAP
2012-03-15Labeling · Supplement 6AP
2007-10-29Labeling · Supplement 4AP
2005-09-28OriginalAP
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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