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FDA ANDA · ANDA088734

MECLIZINE HYDROCHLORIDE

Sponsor: PLIVA

APPLICATION
ANDA088734
TYPE
ANDA
ORIGINAL APPROVAL
1985-12-11
LATEST ACTION
2000-08-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MECLIZINE HYDROCHLORIDEDiscontinued
MECLIZINE HYDROCHLORIDE 25MG · TABLET · ORAL

Approval history

2000-08-29Manufacturing (CMC) · Supplement 13AP
2000-07-07Manufacturing (CMC) · Supplement 14AP
1998-04-03Manufacturing (CMC) · Supplement 11AP
1994-05-11Manufacturing (CMC) · Supplement 10AP
1992-06-04Manufacturing (CMC) · Supplement 9AP
1992-06-04Manufacturing (CMC) · Supplement 7AP
1992-06-04Manufacturing (CMC) · Supplement 8AP
1992-06-04Manufacturing (CMC) · Supplement 6AP
1990-03-22Labeling · Supplement 5AP
1986-07-23Manufacturing (CMC) · Supplement 1AP
1985-12-11OriginalAP
VIEW ON DRUGS@FDA ↗

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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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