An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	208967	ADAPTIS
SUMATRIPTAN	SUMATRIPTAN	20MG/SPRAY	SPRAY;NASAL	Prescription	No	AB	214209	CIPLA
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

Top