Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 020132
Company: GLAXOSMITHKLINE

Other Important Information from FDA

Products on NDA 020132

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IMITREX	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes
IMITREX	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	AB	Yes	No
IMITREX	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020132

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/01/1995	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/09/2025	SUPPL-31	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020080s055,020132s031,020626s029lbl.pdf#page=34 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020080Orig1s055;020132Orig1s031;020626Orig1s029ltr.pdf
03/23/2021	SUPPL-30	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020132s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020132Orig1s030ltr.pdf
12/14/2017	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020132s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020080Orig1s050,020132Orig1s029,020626Origs027ltr.pdf
11/25/2013	SUPPL-28	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-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020132s024s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020132s024,s026ltr.pdf
03/01/2012	SUPPL-24	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020132s024,s026ltr.pdf
08/11/2010	SUPPL-22	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020132s013,s020,s021,s022ltr.pdf
08/11/2010	SUPPL-21	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020132s013,s020,s021,s022ltr.pdf
08/11/2010	SUPPL-20	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020132s013,s020,s021,s022ltr.pdf
06/17/2004	SUPPL-18	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20132slr018ltr.pdf
06/30/2003	SUPPL-15	Manufacturing (CMC)-Formulation, Labeling	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020132_s015_ImitrexTOC.html
07/28/2003	SUPPL-14	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/2003/020132_S014_IMITREX TABLETS, NASAL SPRAY INJ.pdf
08/11/2010	SUPPL-13	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020132s013,s020,s021,s022ltr.pdf
06/25/2001	SUPPL-12	Labeling		Label is not available on this site.
06/25/2001	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
02/09/2001	SUPPL-10	Labeling		Label is not available on this site.
02/09/2001	SUPPL-8	Labeling		Label is not available on this site.
02/09/2001	SUPPL-7	Labeling		Label is not available on this site.
02/24/1998	SUPPL-6	Labeling		Label is not available on this site.
12/16/1997	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/13/1998	SUPPL-3	Efficacy-New Dosing Regimen		Label is not available on this site.
03/28/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020132

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
12/09/2025	SUPPL-31	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020080s055,020132s031,020626s029lbl.pdf#page=34
03/23/2021	SUPPL-30	Labeling-Container/Carton Labels	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020132s030lbl.pdf
03/23/2021	SUPPL-30	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020132s030lbl.pdf
12/14/2017	SUPPL-29	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020132s029lbl.pdf
11/25/2013	SUPPL-28	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020132s028,020626s025lbl.pdf
03/01/2012	SUPPL-26	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020132s024s026lbl.pdf
08/11/2010	SUPPL-22	Labeling	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf
08/11/2010	SUPPL-21	Labeling	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf
08/11/2010	SUPPL-20	Labeling	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf
08/11/2010	SUPPL-13	Labeling	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf

Therapeutic Equivalents for NDA 020132

IMITREX

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IMITREX	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	Yes	AB	020132	GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	078327	AUROBINDO PHARMA
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	076847	DR REDDYS LABS INC
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	206019	IPCA LABS LTD
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	077744	MYLAN
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	078284	ORBION PHARMS
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	219036	VKT PHARMA
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	076933	WATSON LABS
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	200263	ZHEJIANG

TABLET;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IMITREX	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	Yes	AB	020132	GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	078327	AUROBINDO PHARMA
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	076847	DR REDDYS LABS INC
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	206019	IPCA LABS LTD
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	077744	MYLAN
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	078284	ORBION PHARMS
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	219036	VKT PHARMA
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	076933	WATSON LABS
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	200263	ZHEJIANG

TABLET;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IMITREX	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	Yes	AB	020132	GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	078327	AUROBINDO PHARMA
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	076847	DR REDDYS LABS INC
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	206019	IPCA LABS LTD
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	077744	MYLAN
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	078284	ORBION PHARMS
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	219036	VKT PHARMA
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	076933	WATSON LABS
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	200263	ZHEJIANG