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FDA ANDA · ANDA084843

MECLIZINE HYDROCHLORIDE

Sponsor: SANDOZ

APPLICATION
ANDA084843
TYPE
ANDA
ORIGINAL APPROVAL
1976-02-03
LATEST ACTION
2002-05-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MECLIZINE HYDROCHLORIDEPrescription
MECLIZINE HYDROCHLORIDE 12.5MG · TABLET · ORAL

Approval history

2002-05-15Manufacturing (CMC) · Supplement 98AP
2002-03-25Manufacturing (CMC) · Supplement 97AP
2001-04-26Manufacturing (CMC) · Supplement 96AP
1999-05-05Manufacturing (CMC) · Supplement 95AP
1999-03-12Manufacturing (CMC) · Supplement 94AP
1999-03-12Manufacturing (CMC) · Supplement 92AP
1999-03-12Manufacturing (CMC) · Supplement 93AP
1999-03-12Labeling · Supplement 91AP
1996-02-07Manufacturing (CMC) · Supplement 88AP
1995-11-07Manufacturing (CMC) · Supplement 89AP
1989-05-22Labeling · Supplement 85AP
1986-03-21Manufacturing (CMC) · Supplement 82AP
1985-07-05Manufacturing (CMC) · Supplement 77AP
1985-03-01Manufacturing (CMC) · Supplement 76AP
1984-04-12Manufacturing (CMC) · Supplement 72AP
1984-04-12Manufacturing (CMC) · Supplement 71AP
1984-01-25Manufacturing (CMC) · Supplement 68AP
1976-02-03OriginalAP
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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