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FDA ANDA · ANDA085740

MECLIZINE HYDROCHLORIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA085740
TYPE
ANDA
ORIGINAL APPROVAL
1977-07-06
LATEST ACTION
1999-04-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MECLIZINE HYDROCHLORIDEDiscontinued
MECLIZINE HYDROCHLORIDE 25MG · TABLET · ORAL

Approval history

1999-04-13Manufacturing (CMC) · Supplement 29AP
1999-04-13Manufacturing (CMC) · Supplement 28AP
1998-03-25Manufacturing (CMC) · Supplement 27AP
1998-03-25Manufacturing (CMC) · Supplement 26AP
1997-05-23Manufacturing (CMC) · Supplement 25AP
1989-04-18Manufacturing (CMC) · Supplement 19AP
1989-04-18Manufacturing (CMC) · Supplement 21AP
1989-04-18Manufacturing (CMC) · Supplement 20AP
1989-03-28Bioequivalence · Supplement 23AP
1988-05-09Labeling · Supplement 18AP
1987-06-24Manufacturing (CMC) · Supplement 15AP
1987-06-24Manufacturing (CMC) · Supplement 14AP
1982-05-10Manufacturing (CMC) · Supplement 10AP
1982-05-10Manufacturing (CMC) · Supplement 8AP
1982-05-10Manufacturing (CMC) · Supplement 4AP
1982-05-10Manufacturing (CMC) · Supplement 9AP
1977-07-06OriginalAP
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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