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 |