Drugs@FDA: FDA-Approved Drugs
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 |