Drugs@FDA: FDA-Approved Drugs
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150 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ZANTAC 300 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |