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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021698
Company: CHATTEM SANOFI

Products on NDA 021698

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZANTAC 150	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
ZANTAC 150	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021698

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/31/2004	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21698lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21698ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021698s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2019	SUPPL-31	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021698Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021698Orig1s031ltr.pdf
04/04/2019	SUPPL-29	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021698Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021698Orig1s029ltr.pdf
08/26/2016	SUPPL-24	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698Oirg1s023,020520Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021698Orig1s024ltr.pdf
07/27/2016	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698Oirg1s023,020520Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021698Orig1s023,020520Orig1s033ltr.pdf
03/21/2016	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021698Orig1s022ltr.pdf
11/20/2015	SUPPL-20	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021698Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021698Orig1s020Ltr.pdf
12/11/2015	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021698Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021698Orig1s019ltr.pdf
03/12/2015	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021698Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021698Orig1s018ltr.pdf
12/07/2012	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/13/2007	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021698s003ltr.pdf

Labels for NDA 021698

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2019	SUPPL-31	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021698Orig1s031lbl.pdf
04/04/2019	SUPPL-29	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021698Orig1s029lbl.pdf
08/26/2016	SUPPL-24	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698Oirg1s023,020520Orig1s033lbl.pdf
07/27/2016	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698Oirg1s023,020520Orig1s033lbl.pdf
03/21/2016	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698s022lbl.pdf
12/11/2015	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021698Orig1s019lbl.pdf
11/20/2015	SUPPL-20	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021698Orig1s020lbl.pdf
03/12/2015	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021698Orig1s018lbl.pdf
08/31/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21698lbl.pdf

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