APPLICATION
ANDA080728
TYPE
ANDA
ORIGINAL APPROVAL
1973-02-28
LATEST ACTION
1999-10-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DIPHENHYDRAMINE HYDROCHLORIDEDiscontinued
DIPHENHYDRAMINE HYDROCHLORIDE 25MG · CAPSULE · ORAL
Approval history
1999-10-29Manufacturing (CMC) · Supplement 47AP
1991-08-16Labeling · Supplement 45AP
1991-07-02Manufacturing (CMC) · Supplement 44AP
1991-05-31Manufacturing (CMC) · Supplement 42AP
1991-01-28Manufacturing (CMC) · Supplement 43AP
1990-06-29Manufacturing (CMC) · Supplement 41AP
1988-07-21Manufacturing (CMC) · Supplement 39AP
1988-07-21Manufacturing (CMC) · Supplement 40AP
1985-05-16Manufacturing (CMC) · Supplement 35AP
1985-05-16Manufacturing (CMC) · Supplement 36AP
1982-07-06Manufacturing (CMC) · Supplement 31AP
1973-02-28OriginalAP
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.
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.