Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020236
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

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