Drugs@FDA: FDA-Approved Drugs
Company: SMITHKLINE BEECHAM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AXID | NIZATIDINE | 150MG | CAPSULE;ORAL | Discontinued | None | No | No |
| AXID | NIZATIDINE | 300MG | CAPSULE;ORAL | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 04/12/1988 | 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 |
|---|---|---|---|---|---|
| 01/24/2006 | SUPPL-34 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019508s034ltr.pdf |
| 12/23/2005 | SUPPL-33 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019508s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019508s033rev2.pdf | |
| 03/02/2001 | SUPPL-30 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19508S30LTR.PDF |
| 06/19/1998 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/1999 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/22/1996 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/13/1998 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/08/1996 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/23/1996 | SUPPL-23 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/02/1995 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/31/1995 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/13/1993 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/13/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 11/25/1991 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 09/21/1993 | SUPPL-16 | Efficacy-New Indication |
Label is not available on this site. |
||
| 11/25/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 04/11/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 04/10/1990 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/26/1991 | SUPPL-12 | Efficacy-New Indication |
Label is not available on this site. |
||
| 08/29/1990 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/09/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 08/29/1990 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/23/1989 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 02/06/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/23/2005 | SUPPL-33 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019508s033lbl.pdf |