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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020236
Company: GLAXOSMITHKLINE

Other Important Information from FDA

Products on NDA 020236

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020236

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.

Labels for NDA 020236

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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