Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020555
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AXID AR NIZATIDINE 75MG TABLET;ORAL Over-the-counter None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/09/1996 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/26/2004 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20555s006ltr.pdf
10/14/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/01/1998 SUPPL-4 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20555-S3_AxidAr_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20555-S3_AxidAr_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20555S003_AxidAr.cfm
04/01/1998 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20555-S3_AxidAr_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20555-S3_AxidAr_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20555S003_AxidAr.cfm
02/06/1997 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/01/1998 SUPPL-4 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20555-S3_AxidAr_prntlbl.pdf
04/01/1998 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20555-S3_AxidAr_prntlbl.pdf

AXID AR

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 75MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
AXID AR NIZATIDINE 75MG TABLET;ORAL Over-the-counter Yes 020555 PFIZER

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