← FDA DRUG APPROVALS

FDA NDA · NDA010721

MECLIZINE HYDROCHLORIDE

Sponsor: CASPER PHARMA LLC

APPLICATION
NDA010721
TYPE
NDA
ORIGINAL APPROVAL
1957-02-14
LATEST ACTION
2019-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET, TABLET, CHEWABLE
MARKETING STATUS
Prescription

Products

ANTIVERT · ReferencePrescription
MECLIZINE HYDROCHLORIDE 12.5MG · TABLET · ORAL
ANTIVERT · ReferencePrescription
MECLIZINE HYDROCHLORIDE 25MG · TABLET · ORAL
ANTIVERT · ReferencePrescription
MECLIZINE HYDROCHLORIDE 25MG · TABLET, CHEWABLE · ORAL
ANTIVERT · ReferencePrescription
MECLIZINE HYDROCHLORIDE 50MG · TABLET · ORAL

Approval history

2019-06-28Efficacy · Supplement 63 · standard — Letter ↗AP
2018-12-12Labeling · Supplement 62 · standard — Label ↗AP
2018-04-13Efficacy · Supplement 61 · standard — Label ↗AP
2012-10-23Labeling · Supplement 58 · standard — Letter ↗AP
1999-12-14Manufacturing (CMC) · Supplement 54 · standardAP
1999-11-10Manufacturing (CMC) · Supplement 53 · standardAP
1993-09-17Manufacturing (CMC) · Supplement 51 · standardAP
1993-09-02Manufacturing (CMC) · Supplement 52 · standardAP
1993-03-12Manufacturing (CMC) · Supplement 50 · standardAP
1957-02-14UNKNOWN · Original · standardAP
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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