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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020555
Company: HALEON US HOLDINGS

Products on NDA 020555

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020555

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
04/09/2019	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020555Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020555Orig1s010ltr.pdf
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.

Labels for NDA 020555

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/09/2019	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020555Orig1s010lbl.pdf
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

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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	HALEON US HOLDINGS

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