Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020251
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, EFFERVESCENT;ORAL Discontinued None No No
ZANTAC 150 RANITIDINE HYDROCHLORIDE EQ 150MG BASE/PACKET GRANULE, EFFERVESCENT;ORAL Discontinued None No No
ZANTAC 25 RANITIDINE HYDROCHLORIDE EQ 25MG BASE TABLET, EFFERVESCENT;ORAL Discontinued None No 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
03/31/1994 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
09/04/2009 SUPPL-19 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-18 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-17 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-16 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
04/01/2004 SUPPL-15 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20251scf015_zantac_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20251scf015ltr.pdf
01/15/2002 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/2002 SUPPL-11 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-10 Labeling

Label is not available on this site.

10/29/1999 SUPPL-9 Labeling

Label is not available on this site.

10/22/1999 SUPPL-8 Labeling

Label is not available on this site.

10/22/1999 SUPPL-7 Labeling

Label is not available on this site.

10/29/1999 SUPPL-6 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20251S6_zantacefferdose_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20251S6_zantecefferdose.cfm
11/27/1996 SUPPL-5 Labeling

Label is not available on this site.

03/29/1995 SUPPL-4 Labeling

Label is not available on this site.

11/14/1994 SUPPL-3 Labeling

Label is not available on this site.

11/03/1994 SUPPL-1 Labeling

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-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,020251s019lbl.pdf
02/20/2009 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s067,019675s034,020251s018lbl.pdf
04/28/2005 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018703s065,019675s031,020251s016lbl.pdf
04/01/2004 SUPPL-15 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20251scf015_zantac_lbl.pdf

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