APPLICATION
ANDA084657
TYPE
ANDA
ORIGINAL APPROVAL
1975-12-01
LATEST ACTION
2021-09-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MECLIZINE HYDROCHLORIDEDiscontinued
MECLIZINE HYDROCHLORIDE 12.5MG · TABLET · ORAL
MECLIZINE HYDROCHLORIDEDiscontinued
MECLIZINE HYDROCHLORIDE 25MG · TABLET · ORAL
Approval history
2021-09-14Manufacturing (CMC) · Supplement 54 · unknownAP
1987-03-19Manufacturing (CMC) · Supplement 50AP
1986-08-21Manufacturing (CMC) · Supplement 49AP
1986-08-21Manufacturing (CMC) · Supplement 48AP
1982-09-28Manufacturing (CMC) · Supplement 41AP
1975-12-01OriginalAP
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.