Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020095
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| 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150 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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300 | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 03/08/1994 | 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 |
|---|---|---|---|---|---|
| 01/15/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/07/2002 | SUPPL-13 | 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-12 | Labeling |
Label is not available on this site. |
||
| 10/29/1999 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/22/1999 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/22/1999 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 09/12/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1999 | SUPPL-7 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20095S7_zantacgelcapsules_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20095S7_zantacgelcapsules.cfm |
| 11/27/1996 | SUPPL-6 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20251S6_zantecefferdose.cfm |
| 03/29/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/14/1994 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/03/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/04/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |