Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021494
Company: BRAINTREE

Products on NDA 021494

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AXID	NIZATIDINE	15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021494

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/25/2004	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21494_axid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21494ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021494s000_AxidTOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2005	SUPPL-1	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21494s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21494s001ltr.pdf

Labels for NDA 021494

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2005	SUPPL-1	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21494s001lbl.pdf
05/25/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21494_axid_lbl.pdf