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FDA NDA · NDA021494

AXID

Sponsor: BRAINTREE

APPLICATION
NDA021494
TYPE
NDA
ORIGINAL APPROVAL
2004-05-25
LATEST ACTION
2005-03-21
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

AXID · ReferenceDiscontinued
NIZATIDINE 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2005-03-21Manufacturing (CMC) · Supplement 1 · standard — Letter ↗AP
2004-05-25Type 3 - New Dosage Form · Original · standard — Label ↗AP
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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