Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019675
Company: GLAXO GRP LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZANTAC RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML SYRUP;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
12/30/1988 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019675a_clinpharm_rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/04/2009 SUPPL-35 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-34 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-32 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-31 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
04/30/2004 SUPPL-30 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19675scs030ltr.pdf
09/24/2002 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

01/15/2002 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/2002 SUPPL-25 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-24 Labeling

Label is not available on this site.

10/29/1999 SUPPL-23 Labeling

Label is not available on this site.

10/22/1999 SUPPL-22 Labeling

Label is not available on this site.

10/22/1999 SUPPL-21 Labeling

Label is not available on this site.

10/29/1999 SUPPL-20 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19675S20_zantacsyrup_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19675S20_zantacsyrup.cfm
11/27/1996 SUPPL-19 Labeling

Label is not available on this site.

11/03/1994 SUPPL-17 Labeling

Label is not available on this site.

03/29/1995 SUPPL-16 Efficacy-New Indication

Label is not available on this site.

01/30/1995 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/05/1993 SUPPL-14 Labeling

Label is not available on this site.

11/03/1994 SUPPL-13 Labeling

Label is not available on this site.

02/28/1994 SUPPL-12 Labeling

Label is not available on this site.

07/22/1992 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/1992 SUPPL-9 Labeling

Label is not available on this site.

12/20/1990 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/21/1990 SUPPL-7 Labeling

Label is not available on this site.

12/12/1990 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/16/1990 SUPPL-4 Labeling

Label is not available on this site.

11/25/1991 SUPPL-3 Labeling

Label is not available on this site.

05/18/1989 SUPPL-2 Labeling

Label is not available on this site.

08/08/1989 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-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,020251s019lbl.pdf
02/20/2009 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s067,019675s034,020251s018lbl.pdf
04/28/2005 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018703s065,019675s031,020251s016lbl.pdf

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