APPLICATION
ANDA085253
TYPE
ANDA
ORIGINAL APPROVAL
1977-02-07
LATEST ACTION
1990-11-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MECLIZINE HYDROCHLORIDEDiscontinued
MECLIZINE HYDROCHLORIDE 12.5MG · TABLET · ORAL
Approval history
1990-11-16Labeling · Supplement 40AP
1988-06-27Manufacturing (CMC) · Supplement 39AP
1984-04-06Manufacturing (CMC) · Supplement 36AP
1983-06-29Manufacturing (CMC) · Supplement 35AP
1983-03-08Manufacturing (CMC) · Supplement 34AP
1977-02-07OriginalAP
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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