Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020520
Company: SANOFI US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZANTAC 75 RANITIDINE HYDROCHLORIDE EQ 75MG 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
12/19/1995 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
04/04/2019 SUPPL-37 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020520Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020520Orig1s037ltr.pdf
07/27/2016 SUPPL-33 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
01/26/2016 SUPPL-32 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020520Orig1s032LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020520Orig1s032ltr.pdf
09/24/2015 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

11/20/2015 SUPPL-30 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020520Orig1s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020520Orig1s030ltr.pdf
01/30/2015 SUPPL-28 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020520Orig1s028lbl_corrected.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020520Orig1s028ltr.pdf
07/25/2013 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/28/2005 SUPPL-15 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20520s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020520_S015_ZANTAC.pdf
12/03/2002 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/30/2002 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/29/2001 SUPPL-10 Labeling

Label is not available on this site.

11/08/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/07/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/28/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/01/1998 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/08/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/22/1998 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/26/1997 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/08/1998 SUPPL-1 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20520s1_Zantac.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/04/2019 SUPPL-37 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020520Orig1s037lbl.pdf
07/27/2016 SUPPL-33 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698Oirg1s023,020520Orig1s033lbl.pdf
01/26/2016 SUPPL-32 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020520Orig1s032LBL.pdf
11/20/2015 SUPPL-30 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020520Orig1s030lbl.pdf
01/30/2015 SUPPL-28 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020520Orig1s028lbl_corrected.pdf

ZANTAC 75

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 75MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter No 075296 ANI PHARMS INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter No 075167 APOTEX INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter No 207579 AUROBINDO PHARMA LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter No 075294 DR REDDYS LABS LTD
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter No 075497 MYLAN
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter No 076195 PERRIGO
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter No 201745 STRIDES PHARMA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter No 209160 STRIDES PHARMA
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter No 076760 WOCKHARDT
ZANTAC 75 RANITIDINE HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Over-the-counter Yes 020520 SANOFI US

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