APPLICATION
ANDA085269
TYPE
ANDA
ORIGINAL APPROVAL
1976-11-11
LATEST ACTION
1998-06-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MECLIZINE HYDROCHLORIDEDiscontinued
MECLIZINE HYDROCHLORIDE 12.5MG · TABLET · ORAL
Approval history
1998-06-15Manufacturing (CMC) · Supplement 26AP
1998-06-15Manufacturing (CMC) · Supplement 27AP
1989-03-28Manufacturing (CMC) · Supplement 23AP
1988-05-09Labeling · Supplement 19AP
1987-09-14Manufacturing (CMC) · Supplement 14AP
1987-09-14Manufacturing (CMC) · Supplement 13AP
1983-08-26Manufacturing (CMC) · Supplement 11AP
1982-05-04Manufacturing (CMC) · Supplement 9AP
1982-05-04Manufacturing (CMC) · Supplement 4AP
1976-11-11OriginalAP
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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