Drugs@FDA: FDA-Approved Drugs
Company: GLAXOSMITHKLINE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SEREVENT | SALMETEROL XINAFOATE | EQ 0.021MG BASE/INH | AEROSOL, METERED;INHALATION | 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 |
---|---|---|---|---|---|---|---|
02/04/1994 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/28/2004 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20236s030,20692s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21077s022,20236s030,20692s026ltr.pdf | |
08/11/2003 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20236slr028_serevent_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20236slr028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020236_s028_SEREVENT_INHALATION.pdf | |
10/16/2001 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/17/2001 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
06/15/2000 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/29/2000 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
||
02/25/2000 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
12/24/1998 | SUPPL-17 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020236s017_serevent_toc.cfm |
05/11/1998 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
02/05/1998 | SUPPL-15 | Efficacy-New Indication |
Label is not available on this site. |
||
11/26/1997 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
08/06/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/13/1995 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/19/1995 | SUPPL-10 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020236_S010_SERVENT_INHALATION_AEROSOL.pdf |
12/23/1994 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
03/14/1995 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/23/1994 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/15/1996 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/09/1996 | 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 |
---|---|---|---|---|---|
09/28/2004 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20236s030,20692s026lbl.pdf | |
08/11/2003 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20236slr028_serevent_lbl.pdf |