APPLICATION
ANDA088212
TYPE
ANDA
ORIGINAL APPROVAL
1983-05-26
LATEST ACTION
2000-10-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CYPROHEPTADINE HYDROCHLORIDEPrescription
CYPROHEPTADINE HYDROCHLORIDE 4MG · TABLET · ORAL
Approval history
2000-10-06Manufacturing (CMC) · Supplement 14AP
1997-05-12Labeling · Supplement 12AP
1991-03-04Labeling · Supplement 9AP
1989-11-20Labeling · Supplement 8AP
1989-10-10Manufacturing (CMC) · Supplement 6AP
1988-03-10Manufacturing (CMC) · Supplement 4AP
1983-11-16Manufacturing (CMC) · Supplement 1AP
1983-05-26OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.