← FDA DRUG APPROVALS

FDA NDA · NDA020555

AXID AR

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA020555
TYPE
NDA
ORIGINAL APPROVAL
1996-05-09
LATEST ACTION
2019-04-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

AXID AR · ReferenceOver-the-counter
NIZATIDINE 75MG · TABLET · ORAL

Approval history

2019-04-09Labeling · Supplement 10 · standard — Letter ↗AP
2004-10-26Labeling · Supplement 6 · standard — Letter ↗AP
1998-10-14Manufacturing (CMC) · Supplement 5 · standardAP
1998-04-01Efficacy · Supplement 4 · unknown — Review ↗AP
1998-04-01Efficacy · Supplement 3 · unknown — Label ↗AP
1997-02-06Manufacturing (CMC) · Supplement 1 · standardAP
1996-05-09Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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