Sumatriptan Auto-Injector

Brand(s)
Alsuma
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Labs (2014-05-14)
Oldest Current Product
2009-08-31
License(s)
NDA, ANDA
RxNORM
AUTO-INJECTOR\SUMATRIPTAN
FDAOB
INJECTION\INJECTION\HYDROXOCOBALAMIN\rdfq
SUBCUTANEOUS\INJECTION\SUMATRIPTAN SUCCINATE
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\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 auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690138AlsumaNDAPfizer Labs2009-08-31SUMATRIPTANSUBCUTANEOUSINJECTION, SOLUTIONNDA022041109edaaf-f13c-4d4c-aa40-0f9058379158

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1473350276ANDASun Pharma Global Fze2011-06-22SUMATRIPTAN SUCCINATESUBCUTANEOUSINJECTIONANDA090358f235152e-dd8d-4679-9d9f-404fe5ff4fba
2551110693ANDADr. Reddy'S Laboratories Ltd2014-02-24SUMATRIPTAN SUCCINATESUBCUTANEOUSINJECTIONANDA0904954e26764d-ce26-e5ac-e6db-0f1f7a1d5c2b

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drugin other drug docs
1ANDA077332SUMATRIPTAN SUCCINATEPAR PHARMACEUTICAL INC2009-10-09ANDA077332_001Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
2ANDA077871SUMATRIPTAN SUCCINATEPAR STERILE PRODUCTS LLC2009-07-09ANDA077871_001Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
3ANDA077907SUMATRIPTAN SUCCINATETEVA PHARMACEUTICALS USA2009-02-06ANDA077907_001Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
4ANDA078067SUMATRIPTAN SUCCINATETrueSANDOZ CANADA INC2009-02-06ANDA078067_001, ANDA078067_002Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
5ANDA078318SUMATRIPTAN SUCCINATETrueTEVA PARENTERAL MEDICINES INC2009-02-06ANDA078318_001, ANDA078318_002Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
6ANDA078593SUMATRIPTAN SUCCINATEWOCKHARDT LTD2009-02-06ANDA078593_001Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
7ANDA079123SUMATRIPTAN SUCCINATEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2009-02-06ANDA079123_001Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
8ANDA079240SUMATRIPTAN SUCCINATETrueFRESENIUS KABI USA LLC2009-09-18ANDA079240_001, ANDA079240_002Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
9ANDA079242SUMATRIPTAN SUCCINATEFRESENIUS KABI USA LLC2009-03-02ANDA079242_001Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
10ANDA080778ALPHAREDISOLTrueMERCK AND CO INCANDA080778_001Hydroxocobalamin Injectable Solution
11ANDA084629HYDROXOMINTrueBEL MAR LABORATORIES INCANDA084629_001Hydroxocobalamin Injectable Solution
12ANDA084921HYDROXOCOBALAMINTrueABRAXIS PHARMACEUTICAL PRODUCTSANDA084921_001Hydroxocobalamin Injectable Solution
13ANDA085528HYDROXOCOBALAMINTrueWATSON LABORATORIES INCANDA085528_001Hydroxocobalamin Injectable Solution
14ANDA085998HYDROXOCOBALAMINWATSON LABORATORIES INCANDA085998_001Hydroxocobalamin Injectable Solution
15ANDA090310SUMATRIPTAN SUCCINATEINJECTALIA SRL2010-08-11ANDA090310_001Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
16ANDA090314SUMATRIPTAN SUCCINATESAGENT STRIDES LLC2010-06-10ANDA090314_001Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
17ANDA090358SUMATRIPTAN SUCCINATESUN PHARMA GLOBAL FZE2011-06-21ANDA090358_001Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
18ANDA090495SUMATRIPTAN SUCCINATEDR REDDYS LABORATORIES INC2014-01-29ANDA090495_001Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
19ANDA090641SUMATRIPTAN SUCCINATESAGENT AGILA LLC2010-07-28ANDA090641_001Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
20ANDA200183SUMATRIPTAN SUCCINATEHIKMA FARMACEUTICA PORTUGAL SA2013-09-16ANDA200183_001Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
21ANDA202758SUMATRIPTAN SUCCINATEAUROBINDO PHARMA LTD2013-04-23ANDA202758_001Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
22ANDA203322SUMATRIPTAN SUCCINATEMYLAN LABORATORIES LTD2014-04-14ANDA203322_001Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
23NDA020080IMITREXGLAXOSMITHKLINE1992-12-28NDA020080_001, NDA020080_002, NDA020080_003Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
24NDA022041CYANOKITSERB SAS2006-12-15p5834448, TREATMENT OF KNOWN OR SUSPECTED CYANIDE POISONING, SUBSTANCENDA022041_001, NDA022041_002Hydroxocobalamin Injectable Solution
25NDA022239SUMAVEL 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 Injection
Sumatriptan Cartridge
26NDA022377ALSUMAMERIDIAN MEDICAL TECHNOLOGIES INC SUB KING PHARMACEUTICALS INC2010-06-29p7811254, ACUTE TREATMENT OF MIGRAINE ATTACKS, SUBSTANCENDA022377_001Sumatriptan Jet Injector
Sumatriptan Injection
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
13ANDA080778_001discontinuedHYDROXOCOBALAMIN (1MG/ML)INJECTIONFalseALPHAREDISOL
14ANDA084629_001discontinuedHYDROXOCOBALAMIN (1MG/ML)INJECTIONFalseHYDROXOMIN
15ANDA084921_001discontinuedHYDROXOCOBALAMIN (1MG/ML)INJECTIONFalseHYDROXOCOBALAMIN
16ANDA085528_001discontinuedHYDROXOCOBALAMIN (1MG/ML)INJECTIONFalseHYDROXOCOBALAMIN
17ANDA085998_001RXHYDROXOCOBALAMIN (1MG/ML)INJECTIONTrueHYDROXOCOBALAMIN
18ANDA090310_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAP2010-08-11SUMATRIPTAN SUCCINATE
19ANDA090314_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAP2010-06-10SUMATRIPTAN SUCCINATE
20ANDA090358_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAB2011-06-21SUMATRIPTAN SUCCINATE
21ANDA090495_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAB2014-01-29SUMATRIPTAN SUCCINATE
22ANDA090641_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAP2010-07-28SUMATRIPTAN SUCCINATE
23ANDA200183_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAP2013-09-16SUMATRIPTAN SUCCINATE
24ANDA202758_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAP2013-04-23SUMATRIPTAN SUCCINATE
25ANDA203322_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseAP2014-04-14SUMATRIPTAN SUCCINATE
26NDA020080_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONTrueAP1992-12-28IMITREX
27NDA020080_002RXSUMATRIPTAN SUCCINATE (EQ 4MG BASE/0.5ML)SUBCUTANEOUSINJECTIONTrueBX2006-02-01IMITREX
28NDA020080_003RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONTrueAB1996-12-23IMITREX
29NDA022041_001RXHYDROXOCOBALAMIN (5GM/VIAL)INJECTIONTrue2011-04-08CYANOKIT
30NDA022041_002discontinuedHYDROXOCOBALAMIN (2.5GM/VIAL)INJECTIONFalse2006-12-15CYANOKIT
31NDA022239_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONTrueBX2009-07-15SUMAVEL DOSEPRO
32NDA022239_002RXSUMATRIPTAN SUCCINATE (EQ 4MG BASE/0.5ML)SUBCUTANEOUSINJECTIONTrueBX2013-11-26SUMAVEL DOSEPRO
33NDA022377_001RXSUMATRIPTAN SUCCINATE (EQ 6MG BASE/0.5ML)SUBCUTANEOUSINJECTIONFalseBX2010-06-29ALSUMA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5834448 (view patent)2016-11-14NDA022041Hydroxocobalamin Injectable Solution
2p5891086 (view patent)2014-07-27NDA022239Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
3p5957886 (view patent)2016-03-08NDA022239Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
4p6135979 (view patent)2017-03-21NDA022239Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
5p6174304 (view patent)2015-12-13NDA022239Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
6p6251091 (view patent)2016-12-09NDA022239Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
7p6280410 (view patent)2017-03-27NDA022239Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
8p6681810 (view patent)2015-12-13NDA022239Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
9p7776007 (view patent)2026-11-22NDA022239Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
10p7811254 (view patent)2027-08-26NDA022377Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
11p7901385 (view patent)2026-07-31NDA022239Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
12p8118771 (view patent)2023-08-10NDA022239Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
13p8241243 (view patent)2023-08-10NDA022239Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
14p8241244 (view patent)2022-11-21NDA022239Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
15p8267903 (view patent)2023-03-18NDA022239Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
16p8287489 (view patent)2024-12-06NDA022239Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
17p8343130 (view patent)2022-10-18NDA022239Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge
18p8491524 (view patent)2022-11-21NDA022239Sumatriptan Jet Injector
Sumatriptan Injection
Sumatriptan Cartridge

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1109edaaf-f13c-4d4c-aa40-0f9058379158 (view SPL)These highlights do not include all the information needed to use ALSUMA safely and effectively. See full prescribing information for ALSUMA. ALSUMA (sumatriptan injection) 6 mg/0.5 mL for subcutaneous useInitial U.S. Approval: 1992prescriptionHuman PrescriptionPfizer LabsMANUFACTURE2014-05-147000690138
24e26764d-ce26-e5ac-e6db-0f1f7a1d5c2b (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 . SUMATRIPTAN injection, USP, for subcutaneous useInitial U.S. Approval: 1992prescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2015-07-2210551110693
355f21004-9ce6-4648-94d9-73ab2c7873e8 (view SPL)These highlights do not include all the information needed to use ALSUMA safely and effectively. See full prescribing information for ALSUMA. ALSUMA (sumatriptan injection) 6 mg/0.5 mL Auto-Injector for subcutaneous use Initial U.S. Approval: 1992prescriptionHuman PrescriptionUs Worldmeds, Llc2010-06-211275050002
4f235152e-dd8d-4679-9d9f-404fe5ff4fba (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.SUMATRIPTAN injection,for subcutaneous useInitial U.S. Approval: 1992prescriptionHuman PrescriptionSun Pharma Global FzeANALYSIS, MANUFACTURE2015-09-3010473350276

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