Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020080
Company: GLAXOSMITHKLINE

• Other Important Information from FDA

Products on NDA 20080

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IMITREX	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Discontinued	None	Yes	No
IMITREX STATDOSE	SUMATRIPTAN SUCCINATE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	AB	Yes	Yes
IMITREX STATDOSE	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	AB	Yes	Yes

Labels for NDA 020080

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2021	SUPPL-54	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020080s054lbl.pdf
03/23/2021	SUPPL-53	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020080Orig1s053lbl.pdf
03/23/2021	SUPPL-53	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020080Orig1s053lbl.pdf
07/17/2018	SUPPL-52	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020080s052lbl.pdf
12/14/2017	SUPPL-50	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020080s050lbl.pdf
11/19/2015	SUPPL-49	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020080s049lbl.pdf
06/11/2015	SUPPL-48	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020080s048lbl.pdf
10/02/2012	SUPPL-45	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf
10/02/2012	SUPPL-41	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf
10/02/2012	SUPPL-40	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf
10/02/2012	SUPPL-39	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020080s039s040s041s045lbl.pdf
07/21/2010	SUPPL-38	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020080s038lbl.pdf
02/01/2006	SUPPL-36	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020080s036lbl.pdf