Sumatriptan Injection

Brand(s)
Imitrex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sandoz Inc (2015-08-06)
Oldest Current Product
2008-09-09
License(s)
NDA, ANDA
RxNORM
INJECTION\SUMATRIPTAN
FDAOB
SUBCUTANEOUS\INJECTION\SUMATRIPTAN SUCCINATE
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\SUMATRIPTAN SUCCINATE
SUBCUTANEOUS\INJECTION\SUMATRIPTAN
SUBCUTANEOUS\INJECTION\SUMATRIPTAN SUCCINATE
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\SUMATRIPTAN
SUBCUTANEOUS\INJECTION\SUMATRIPTAN

product(s) by strength(s)

0.5 ml sumatriptan 12 mg/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813174NDASandoz Inc2008-09-09SUMATRIPTAN SUCCINATESUBCUTANEOUSINJECTION, SOLUTIONNDA020080e6058c90-eae2-4207-ba7d-563fe4a51112

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439638ANDAWest-Ward Pharmaceutical Corp2013-09-16SUMATRIPTAN SUCCINATESUBCUTANEOUSINJECTIONANDA2001832b417f8c-9e5b-45a1-b8af-183818258df9
2007037351ANDATeva Parenteral Medicines, Inc2009-02-06SUMATRIPTAN SUCCINATESUBCUTANEOUSINJECTIONANDA07790724259865-233b-4258-a01b-e895a873f2c4
3420230121ANDAPar Pharmaceutical Inc.2009-08-06SUMATRIPTAN SUCCINATESUBCUTANEOUSINJECTIONANDA07787105adc16c-4c2b-46f0-b810-bb18d4106dc5
4551500173ANDAAuromedics Pharma Llc2013-04-23SUMATRIPTAN SUCCINATESUBCUTANEOUSINJECTION, SOLUTIONANDA202758c009976a-4e29-4aeb-9e55-a88766ebb1fb
5556480728ANDAWockhardt Limited2009-02-06SUMATRIPTAN SUCCINATESUBCUTANEOUSINJECTIONANDA078593cc5fed6e-37b5-415c-af2c-31e2bfb83c7c
6633230273ANDAApp Pharmaceuticals, Llc2011-04-12SUMATRIPTANSUBCUTANEOUSINJECTIONANDA079242b183c7ba-2cc6-4854-a9a6-71ccd3592586
7646790728ANDAWockhardt Usa Llc.2009-02-06SUMATRIPTAN SUCCINATESUBCUTANEOUSINJECTIONANDA078593e0917960-87bf-4650-b60b-64bef2ccc4d6
8761260072ANDAAgila Specialties Private Limited2014-04-15SUMATRIPTAN SUCCINATESUBCUTANEOUSINJECTIONANDA203322e2ffd17b-fa4e-4d7c-9537-1eeb04f3beed

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drugin other drug docs
1ANDA077332SUMATRIPTAN SUCCINATEPAR PHARMACEUTICAL INC2009-10-09ANDA077332_001Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
2ANDA077871SUMATRIPTAN SUCCINATEPAR STERILE PRODUCTS LLC2009-07-09ANDA077871_001Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
3ANDA077907SUMATRIPTAN SUCCINATETEVA PHARMACEUTICALS USA2009-02-06ANDA077907_001Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
4ANDA078067SUMATRIPTAN SUCCINATETrueSANDOZ CANADA INC2009-02-06ANDA078067_001, ANDA078067_002Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
5ANDA078318SUMATRIPTAN SUCCINATETrueTEVA PARENTERAL MEDICINES INC2009-02-06ANDA078318_001, ANDA078318_002Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
6ANDA078593SUMATRIPTAN SUCCINATEWOCKHARDT LTD2009-02-06ANDA078593_001Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
7ANDA079123SUMATRIPTAN SUCCINATEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2009-02-06ANDA079123_001Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
8ANDA079240SUMATRIPTAN SUCCINATETrueFRESENIUS KABI USA LLC2009-09-18ANDA079240_001, ANDA079240_002Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
9ANDA079242SUMATRIPTAN SUCCINATEFRESENIUS KABI USA LLC2009-03-02ANDA079242_001Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
10ANDA090310SUMATRIPTAN SUCCINATEINJECTALIA SRL2010-08-11ANDA090310_001Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
11ANDA090314SUMATRIPTAN SUCCINATESAGENT STRIDES LLC2010-06-10ANDA090314_001Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
12ANDA090358SUMATRIPTAN SUCCINATESUN PHARMA GLOBAL FZE2011-06-21ANDA090358_001Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
13ANDA090495SUMATRIPTAN SUCCINATEDR REDDYS LABORATORIES INC2014-01-29ANDA090495_001Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
14ANDA090641SUMATRIPTAN SUCCINATESAGENT AGILA LLC2010-07-28ANDA090641_001Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
15ANDA200183SUMATRIPTAN SUCCINATEHIKMA FARMACEUTICA PORTUGAL SA2013-09-16ANDA200183_001Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
16ANDA202758SUMATRIPTAN SUCCINATEAUROBINDO PHARMA LTD2013-04-23ANDA202758_001Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
17ANDA203322SUMATRIPTAN SUCCINATEMYLAN LABORATORIES LTD2014-04-14ANDA203322_001Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
18NDA020080IMITREXGLAXOSMITHKLINE1992-12-28NDA020080_001, NDA020080_002, NDA020080_003Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
19NDA022239SUMAVEL DOSEPROENDO VENTURES LTD IRELAND2009-07-15p8241243, SUBSTANCE
p8287489, SUBSTANCE
p8241244, SUBSTANCE
p6135979, SUBSTANCE
p5957886, SUBSTANCE
p7901385, SUBSTANCE
p7776007, SUBSTANCE
p8267903, SUBSTANCE
p6681810, SUBSTANCE
p5891086, SUBSTANCE
p6174304, SUBSTANCE
p6251091, SUBSTANCE
p8491524, SUBSTANCE
p8343130, SUBSTANCE
p8118771, SUBSTANCE
p6280410, SUBSTANCE
NDA022239_001, NDA022239_002Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
20NDA022377ALSUMAMERIDIAN MEDICAL TECHNOLOGIES INC SUB KING PHARMACEUTICALS INC2010-06-29p7811254, ACUTE TREATMENT OF MIGRAINE ATTACKS, SUBSTANCENDA022377_001Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077332_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAP2009-10-09SUMATRIPTAN SUCCINATE
2ANDA077871_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAP2009-07-09SUMATRIPTAN SUCCINATE
3ANDA077907_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAP2009-02-06SUMATRIPTAN SUCCINATE
4ANDA078067_001discontinuedSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalse2009-02-06SUMATRIPTAN SUCCINATE
5ANDA078067_002discontinuedSUMATRIPTAN SUCCINATE (EQ 4MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalse2009-02-06SUMATRIPTAN SUCCINATE
6ANDA078318_001discontinuedSUMATRIPTAN SUCCINATE (EQ 4MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalse2009-02-06SUMATRIPTAN SUCCINATE
7ANDA078318_002discontinuedSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalse2009-02-06SUMATRIPTAN SUCCINATE
8ANDA078593_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAP2009-02-06SUMATRIPTAN SUCCINATE
9ANDA079123_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAP2009-02-06SUMATRIPTAN SUCCINATE
10ANDA079240_001discontinuedSUMATRIPTAN SUCCINATE (EQ 4MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalse2009-09-18SUMATRIPTAN SUCCINATE
11ANDA079240_002discontinuedSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalse2009-09-18SUMATRIPTAN SUCCINATE
12ANDA079242_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAP2009-03-02SUMATRIPTAN SUCCINATE
13ANDA090310_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAP2010-08-11SUMATRIPTAN SUCCINATE
14ANDA090314_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAP2010-06-10SUMATRIPTAN SUCCINATE
15ANDA090358_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAB2011-06-21SUMATRIPTAN SUCCINATE
16ANDA090495_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAB2014-01-29SUMATRIPTAN SUCCINATE
17ANDA090641_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAP2010-07-28SUMATRIPTAN SUCCINATE
18ANDA200183_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAP2013-09-16SUMATRIPTAN SUCCINATE
19ANDA202758_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAP2013-04-23SUMATRIPTAN SUCCINATE
20ANDA203322_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAP2014-04-14SUMATRIPTAN SUCCINATE
21NDA020080_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONTrueAP1992-12-28IMITREX
22NDA020080_002RXSUMATRIPTAN SUCCINATE (EQ 4MG BASE/0.5ML)SUBCUTANEOUSINJECTIONTrueBX2006-02-01IMITREX
23NDA020080_003RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONTrueAB1996-12-23IMITREX
24NDA022239_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONTrueBX2009-07-15SUMAVEL DOSEPRO
25NDA022239_002RXSUMATRIPTAN SUCCINATE (EQ 4MG BASE/0.5ML)SUBCUTANEOUSINJECTIONTrueBX2013-11-26SUMAVEL DOSEPRO
26NDA022377_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseBX2010-06-29ALSUMA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5891086 (view patent)2014-07-27NDA022239Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
2p5957886 (view patent)2016-03-08NDA022239Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
3p6135979 (view patent)2017-03-21NDA022239Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
4p6174304 (view patent)2015-12-13NDA022239Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
5p6251091 (view patent)2016-12-09NDA022239Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
6p6280410 (view patent)2017-03-27NDA022239Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
7p6681810 (view patent)2015-12-13NDA022239Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
8p7776007 (view patent)2026-11-22NDA022239Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
9p7811254 (view patent)2027-08-26NDA022377Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
10p7901385 (view patent)2026-07-31NDA022239Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
11p8118771 (view patent)2023-08-10NDA022239Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
12p8241243 (view patent)2023-08-10NDA022239Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
13p8241244 (view patent)2022-11-21NDA022239Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
14p8267903 (view patent)2023-03-18NDA022239Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
15p8287489 (view patent)2024-12-06NDA022239Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
16p8343130 (view patent)2022-10-18NDA022239Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge
17p8491524 (view patent)2022-11-21NDA022239Sumatriptan Jet Injector
Sumatriptan Auto-Injector
Sumatriptan Cartridge

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
105adc16c-4c2b-46f0-b810-bb18d4106dc5 (view SPL)Sumatriptan Succinate InjectionprescriptionHuman PrescriptionPar Pharmaceutical Inc.2009-09-042420230121
224259865-233b-4258-a01b-e895a873f2c4 (view SPL)Sumatriptan Succinate InjectionprescriptionHuman PrescriptionTeva Parenteral Medicines, IncManufacture2009-10-282007037351
32b417f8c-9e5b-45a1-b8af-183818258df9 (view SPL)These highlights do not include all the information needed to use sumatriptan safely and effectively. See full prescribing information for sumatriptan. SU MATRIPTAN Injection, USP, for subcutaneous use Initial U.S. Approval: 1992prescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpANALYSIS, LABEL, MANUFACTURE, PACK2015-10-134001439638
4b183c7ba-2cc6-4854-a9a6-71ccd3592586 (view SPL)Sumatriptan Succinate InjectionprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2011-04-121633230273
5c009976a-4e29-4aeb-9e55-a88766ebb1fb (view SPL)These highlights do not include all the information needed to use sumatriptan injection safely and effectively. See full prescribing information for sumatriptan injection. SUMATRIPTANinjection USP, for subcutaneous useInitial U.S. Approval: 1992prescriptionHuman PrescriptionAuromedics Pharma LlcANALYSIS, API MANUFACTURE, MANUFACTURE2015-07-215551500173
6cc5fed6e-37b5-415c-af2c-31e2bfb83c7c (view SPL)PRESCRIBING INFORMATIONSumatriptan Succinate InjectionprescriptionHuman PrescriptionWockhardt LimitedManufacture2012-03-051556480728
7e0917960-87bf-4650-b60b-64bef2ccc4d6 (view SPL)PRESCRIBING INFORMATIONSumatriptan Succinate InjectionprescriptionHuman PrescriptionWockhardt Usa Llc.Manufacture2012-02-151646790728
8e2ffd17b-fa4e-4d7c-9537-1eeb04f3beed (view SPL)These highlights do not include all the information needed to use sumatriptan injection USP safely and effectively. See full prescribing information for sumatriptan injection USP. SUMATRIPTAN Injection, USP for subcutaneous use Initial U.S. Approval: 1992prescriptionHuman PrescriptionAgila Specialties Private LimitedAnalysis, Manufacture, Pack, Sterilize2014-04-152761260072
9e6058c90-eae2-4207-ba7d-563fe4a51112 (view SPL)These highlights do not include all the information needed to use Sumatriptan Succinate safely and effectively. See full prescribing information for Sumatriptan Succinate.Sumatriptan Succinate injection, for subcutaneous useInitial U.S. Approval: 1992prescriptionHuman PrescriptionSandoz Inc2015-08-0613007813174, 007813169, 007813170, 007813172, 007813173Sumatriptan Cartridge
10fee7d073-0b99-48f2-7985-0d8cf970894b (view SPL)These highlights do not include all the information needed to use IMITREX safely and effectively. See full prescribing information for IMITREX.IMITREX (sumatriptan succinate) injection, for subcutaneous use Initial U.S. Approval: 1992prescriptionHuman PrescriptionGlaxosmithkline Llc2015-11-2314001730449, 001730478, 001730479, 001730739Sumatriptan Cartridge

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII