Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021698
Company: SANOFI US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZANTAC 150 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Over-the-counter None Yes Yes
ZANTAC 150 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Over-the-counter 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
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
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-Package Insert, Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021698s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

ZANTAC 150

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

TABLET;ORAL; EQ 150MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Over-the-counter No 200172 APOTEX INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Over-the-counter No 207578 AUROBINDO PHARMA LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Over-the-counter No 078192 DR REDDYS LABS LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Over-the-counter No 210243 GRANULES INDIA LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Over-the-counter No 091429 PERRIGO R AND D
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Over-the-counter No 200536 STRIDES PHARMA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Over-the-counter No 209161 STRIDES PHARMA
ZANTAC 150 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Over-the-counter Yes 021698 SANOFI US

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

TABLET;ORAL; EQ 150MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Over-the-counter No 200172 APOTEX INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Over-the-counter No 207578 AUROBINDO PHARMA LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Over-the-counter No 078192 DR REDDYS LABS LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Over-the-counter No 210243 GRANULES INDIA LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Over-the-counter No 091429 PERRIGO R AND D
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Over-the-counter No 200536 STRIDES PHARMA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Over-the-counter No 209161 STRIDES PHARMA
ZANTAC 150 RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Over-the-counter Yes 021698 SANOFI US

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