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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020251
Company: GLAXO GRP LTD

Products on NDA 020251

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020251

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.

Labels for NDA 020251

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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