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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020626
Company: GLAXOSMITHKLINE

Other Important Information from FDA

Products on NDA 020626

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IMITREX	SUMATRIPTAN	5MG/SPRAY	SPRAY;NASAL	Prescription	AB	Yes	Yes
IMITREX	SUMATRIPTAN	10MG/SPRAY	SPRAY;NASAL	Discontinued	None	No	No
IMITREX	SUMATRIPTAN	20MG/SPRAY	SPRAY;NASAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020626

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/26/1997	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020626_imitrex_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/14/2017	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020626s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020080Orig1s050,020132Orig1s029,020626Origs027ltr.pdf
03/25/2016	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
11/25/2013	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020132s028,020626s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020132Orig1s028,020626Orig1s025ltr.pdf
03/01/2012	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020626s018s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020626s018,s022ltr.pdf
03/01/2012	SUPPL-18	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020626s018,s022ltr.pdf
07/21/2010	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020626s013,s015,s016ltr.pdf
07/21/2010	SUPPL-15	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020626s013,s015,s016ltr.pdf
07/21/2010	SUPPL-13	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020626s013,s015,s016ltr.pdf
07/28/2003	SUPPL-7	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20132slr014,20626slr007,20080slr030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020626_S007_IMITREX TABLETS, NASAL SPRAY INJECTION.pdf
05/10/2002	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20626s6ltr.pdf
10/13/2004	SUPPL-4	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20626s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20626s004ltr.pdf
12/11/2000	SUPPL-3	Labeling		Label is not available on this site.
06/01/2000	SUPPL-2	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020626_s002_IMITREX_NASAL_SPRAY.pdf
06/01/2000	SUPPL-1	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020626_s001_IMITREX_NASAL_SPRAY.pdf

Labels for NDA 020626

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/14/2017	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020626s027lbl.pdf
11/25/2013	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020132s028,020626s025lbl.pdf
03/01/2012	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020626s018s022lbl.pdf
07/21/2010	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf
07/21/2010	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf
07/21/2010	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020626s013s015s016lbl.pdf
10/13/2004	SUPPL-4	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20626s004lbl.pdf

Therapeutic Equivalents for NDA 020626

IMITREX

SPRAY;NASAL; 5MG/SPRAY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IMITREX	SUMATRIPTAN	5MG/SPRAY	SPRAY;NASAL	Prescription	Yes	AB	020626	GLAXOSMITHKLINE
SUMATRIPTAN	SUMATRIPTAN	5MG/SPRAY	SPRAY;NASAL	Prescription	No	AB	204841	LANNETT CO INC
SUMATRIPTAN	SUMATRIPTAN	5MG/SPRAY	SPRAY;NASAL	Prescription	No	AB	213465	PADAGIS ISRAEL
SUMATRIPTAN	SUMATRIPTAN	5MG/SPRAY	SPRAY;NASAL	Prescription	No	AB	213650	PERRIGO UK FINCO

SPRAY;NASAL; 20MG/SPRAY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IMITREX	SUMATRIPTAN	20MG/SPRAY	SPRAY;NASAL	Prescription	Yes	AB	020626	GLAXOSMITHKLINE
SUMATRIPTAN	SUMATRIPTAN	20MG/SPRAY	SPRAY;NASAL	Prescription	No	AB	214209	CIPLA
SUMATRIPTAN	SUMATRIPTAN	20MG/SPRAY	SPRAY;NASAL	Prescription	No	AB	208967	FLORIDA
SUMATRIPTAN	SUMATRIPTAN	20MG/SPRAY	SPRAY;NASAL	Prescription	No	AB	204841	LANNETT CO INC
SUMATRIPTAN	SUMATRIPTAN	20MG/SPRAY	SPRAY;NASAL	Prescription	No	AB	213465	PADAGIS ISRAEL

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