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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021494
Company: BRAINTREE
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AXID NIZATIDINE 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION;ORAL Discontinued None Yes No
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.cfm
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
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
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