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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020983
Company: GLAXOSMITHKLINE

Products on NDA 020983

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VENTOLIN HFA	ALBUTEROL SULFATE	EQ 0.09MG BASE/INH	AEROSOL, METERED;INHALATION	Prescription	BX	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020983

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/19/2001	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20983lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20983ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-983_Ventolin-HFA.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2021	SUPPL-41	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020983s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020983Orig1s041ltr.pdf
12/16/2019	SUPPL-36	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020983s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020983Orig1s036ltr.pdf
08/14/2015	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
01/12/2015	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
12/19/2014	SUPPL-32	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020983s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020983Orig1s032ltr.pdf
06/17/2014	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
01/03/2014	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
01/21/2014	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
09/06/2012	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020983s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020983Orig1s027ltr.pdf
03/26/2008	SUPPL-16	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020983s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020983s016ltr.pdf
08/27/2008	SUPPL-13			Label is not available on this site.
03/17/2006	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/19/2005	SUPPL-9	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020983s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020983s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020983Orig1s009Approv.pdf
09/10/2002	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/04/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
10/25/2001	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/09/2001	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020983

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2021	SUPPL-41	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020983s041lbl.pdf
12/16/2019	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020983s036lbl.pdf
12/19/2014	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020983s032lbl.pdf
09/06/2012	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020983s027lbl.pdf
03/26/2008	SUPPL-16	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020983s016lbl.pdf
04/19/2005	SUPPL-9	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020983s009lbl.pdf
04/19/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20983lbl.pdf

Therapeutic Equivalents for NDA 020983

VENTOLIN HFA

There are no Therapeutic Equivalents.

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