Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018703
Company: GLAXO GRP LTD
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 300 RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Discontinued 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
06/09/1983 ORIG-1 Approval Type 1 - New Molecular Entity 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
09/04/2009 SUPPL-68 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,020251s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018703s068,019675s035,020251s019ltr.pdf
02/20/2009 SUPPL-67 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s067,019675s034,020251s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018703s067,019675s034,020251s018ltr.pdf
07/12/2006 SUPPL-66 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018703s066, 019675s032, 020251s017_ltr.pdf
04/28/2005 SUPPL-65 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018703s065,019675s031,020251s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018703s065,019675s031,020251s016ltr.pdf
01/15/2002 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/2002 SUPPL-61 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18703s61ltr.pdf
05/09/2001 SUPPL-60 Labeling

Label is not available on this site.

10/29/1999 SUPPL-59 Labeling

Label is not available on this site.

10/22/1999 SUPPL-58 Labeling

Label is not available on this site.

10/22/1999 SUPPL-57 Labeling

Label is not available on this site.

10/29/1999 SUPPL-56 Efficacy-Labeling Change With Clinical Data Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18703S56_zantac_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18703S56_zantac.cfm
11/27/1996 SUPPL-55 Labeling

Label is not available on this site.

11/03/1994 SUPPL-53 Labeling

Label is not available on this site.

01/26/1996 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

10/19/1994 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

03/29/1995 SUPPL-50 Efficacy-New Indication

Label is not available on this site.

06/03/1993 SUPPL-49 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/05/1993 SUPPL-48 Labeling

Label is not available on this site.

11/03/1994 SUPPL-47 Efficacy-New Indication

Label is not available on this site.

02/28/1994 SUPPL-46 Efficacy-New Dosing Regimen

Label is not available on this site.

07/22/1992 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

07/02/1992 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/19/1992 SUPPL-42 Efficacy-New Indication

Label is not available on this site.

12/20/1990 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

11/21/1990 SUPPL-40 Labeling

Label is not available on this site.

12/12/1990 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

07/16/1990 SUPPL-37 Labeling

Label is not available on this site.

11/25/1991 SUPPL-36 Labeling

Label is not available on this site.

01/04/1991 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/1991 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1989 SUPPL-33 Labeling

Label is not available on this site.

02/06/1990 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

08/08/1989 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

10/25/1988 SUPPL-30 Labeling

Label is not available on this site.

02/03/1989 SUPPL-29 Labeling

Label is not available on this site.

09/29/1988 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1988 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1988 SUPPL-26 Labeling

Label is not available on this site.

05/20/1988 SUPPL-25 Labeling

Label is not available on this site.

10/29/1987 SUPPL-24 Labeling

Label is not available on this site.

08/27/1987 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/24/1987 SUPPL-22 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/06/1987 SUPPL-20 Labeling

Label is not available on this site.

10/27/1986 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/27/1986 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1986 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/09/1985 SUPPL-16 Labeling

Label is not available on this site.

02/20/1986 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1985 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/23/1985 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/09/1985 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1985 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/04/1985 SUPPL-10 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/30/1986 SUPPL-8 Efficacy-New Indication

Label is not available on this site.

09/13/1984 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/09/1985 SUPPL-6 Efficacy-New Dosing Regimen

Label is not available on this site.

08/27/1984 SUPPL-5 Labeling

Label is not available on this site.

05/30/1986 SUPPL-4 Efficacy-New Indication

Label is not available on this site.

02/28/1984 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1985 SUPPL-2 Efficacy

Label is not available on this site.

01/05/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/04/2009 SUPPL-68 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,020251s019lbl.pdf
02/20/2009 SUPPL-67 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s067,019675s034,020251s018lbl.pdf
04/28/2005 SUPPL-65 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018703s065,019675s031,020251s016lbl.pdf

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