argatroban Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eagle Pharmaceuticals, Inc. (2014-09-09)
Oldest Current Product
2000-11-28
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
INJECTABLE SOLUTION\ARGATROBAN
FDAOB
INJECTION\INJECTION\ARGATROBAN\rdfq
IV (INFUSION)\INJECTION\ARGATROBAN\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\ARGATROBAN
INTRAVENOUS\INJECTION\ARGATROBAN
INTRAVENOUS\SOLUTION\ARGATROBAN
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\ARGATROBAN: ARGATROBAN ANHYDROUS
INTRAVENOUS\INJECTION\ARGATROBAN
INTRAVENOUS\INJECTION\ARGATROBAN ANHYDROUS
INTRAVENOUS\SOLUTION\ARGATROBAN

product(s) by strength(s)

argatroban 1 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813285NDASandoz Inc2011-05-09ARGATROBANINTRAVENOUSSOLUTIONNDA022485cea3f6aa-cd1c-4152-98bb-bbb7b977497a
2423670202NDAEagle Pharmaceuticals, Inc.2011-09-06ARGATROBANINTRAVENOUSINJECTIONNDA02243434fb6cda-e236-4803-b599-a9b048d33513

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813314NDA AUTHORIZED GENERICSandoz Inc2011-09-06ARGATROBANINTRAVENOUSINJECTIONNDA022434641c4c2b-87a3-44ca-a126-f83a4d58e988
2007819314NDA AUTHORIZED GENERICSandoz Inc2011-09-06ARGATROBANINTRAVENOUSINJECTIONNDA022434ad7a4516-210f-4ad9-af75-dc11b1376d50

argatroban 100 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000074407NDAGlaxosmithkline Llc2000-11-28ARGATROBANINTRAVENOUSINJECTION, SOLUTIONNDA0208839c9616c0-a299-4fd5-c8ae-79e6db453595
2001439674NDAWest-Ward Pharmaceutical Corp2012-01-05ARGATROBANINTRAVENOUSINJECTIONNDA2030490cdf3f67-5bf3-4d58-b330-03febdc652bf

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1420230182ANDAPar Pharmaceutical Inc.2015-06-01ARGATROBANINTRAVENOUSINJECTIONANDA091665d4e5238f-2378-424e-bda2-f1a2cf874041

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA091665ARGATROBANPAR STERILE PRODUCTS LLC2014-06-30ANDA091665_001
2ANDA202626ARGATROBANMYLAN INSTITUTIONAL LLC2014-06-30ANDA202626_001
3NDA020883ARGATROBANPFIZER INC2000-06-30NDA020883_001
4NDA022434ARGATROBAN IN SODIUM CHLORIDEEAGLE PHARMACEUTICALS INC2011-06-29p7589106, METHOD OF TREATING THROMBOSIS, SUBSTANCE
p7687516, METHOD OF TREATING AN ARGATROBAN TREATABLE CONDITION, SUBSTANCE
NDA022434_001
5NDA022485ARGATROBAN IN SODIUM CHLORIDESANDOZ INC2011-05-09NDA022485_001
6NDA201811ARGATROBANFRESENIUS KABI USA LLC2015-03-23NDA201811_001
7NDA203049ARGATROBANHIKMA PHARM CO LTD2012-01-05NDA203049_001
8NDA206769ARGATROBAN IN 0.9% SODIUM CHLORIDETEVA PHARMACEUTICALS USA2014-12-15NDA206769_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA091665_001RXARGATROBAN (250MG/2.5ML)INJECTIONFalseAP2014-06-30ARGATROBAN
2ANDA202626_001RXARGATROBAN (250MG/2.5ML)INJECTIONFalseAP2014-06-30ARGATROBAN
3NDA020883_001RXARGATROBAN (250MG/2.5ML)INJECTIONTrueAP2000-06-30ARGATROBAN
4NDA022434_001RXARGATROBAN (50MG/50ML)INJECTIONTrue2011-06-29ARGATROBAN IN SODIUM CHLORIDE
5NDA022485_001RXARGATROBAN (125MG/125ML)INJECTIONTrue2011-05-09ARGATROBAN IN SODIUM CHLORIDE
6NDA201811_001RXARGATROBAN (250MG/2.5ML)INJECTIONFalseAP2015-03-23ARGATROBAN
7NDA203049_001RXARGATROBAN (250MG/2.5ML)INJECTIONFalseAP2012-01-05ARGATROBAN
8NDA206769_001RXARGATROBAN (250MG/250ML)INJECTIONFalse2014-12-15ARGATROBAN IN 0.9% SODIUM CHLORIDE

patent(s)

#idexpiration dateapplication(s)
1p7589106 (view patent)2027-09-26NDA022434
2p7687516 (view patent)2027-09-26NDA022434

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10cdf3f67-5bf3-4d58-b330-03febdc652bf (view SPL)These highlights do not include all the information needed to use Argatroban Injection safely and effectively. See full prescribing information for Argatroban Injection. Argatroban Injection for Intravenousadministration Initial U.S. Approval: 2000prescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2014-03-3112001439674
234fb6cda-e236-4803-b599-a9b048d33513 (view SPL)These highlights do not include all the information needed to use Argatroban safely and effectively. See full prescribing information for Argatroban. ARGATROBAN INJECTION, aqueous solution for intravenous infusion onlyInitial U.S. Approval: 2000prescriptionHuman PrescriptionEagle Pharmaceuticals, Inc.MANUFACTURE2014-09-094423670202
335db0a86-76af-4f5e-a5c6-0a664f53f6da (view SPL)These highlights do not include all the information needed to use Argatroban safely and effectively. See full prescribing information for Argatroban. ARGATROBAN INJECTION, aqueous solution for intravenous infusion onlyInitial U.S. Approval: 2000prescriptionHuman PrescriptionEagle Pharmaceuticals, Inc.MANUFACTURE2014-09-095423670203
4641c4c2b-87a3-44ca-a126-f83a4d58e988 (view SPL)These highlights do not include all the information needed to use Argatroban safely and effectively. See full prescribing information for Argatroban. ARGATROBAN INJECTION, aqueous solution for intravenous infusion onlyInitial U.S. Approval: 2000prescriptionHuman PrescriptionSandoz IncMANUFACTURE2014-07-315007813314
59c9616c0-a299-4fd5-c8ae-79e6db453595 (view SPL)These highlights do not include all the information needed to use ARGATROBAN INJECTION safely and effectively. See full prescribing information for ARGATROBAN INJECTION. ARGATROBAN INJECTION, for intravenous infusion onlyInitial U.S. Approval: 2000prescriptionHuman PrescriptionGlaxosmithkline Llc2014-03-318000074407
6ad7a4516-210f-4ad9-af75-dc11b1376d50 (view SPL)These highlights do not include all the information needed to use Argatroban safely and effectively. See full prescribing information for Argatroban. ARGATROBAN INJECTION, aqueous solution for intravenous infusion onlyInitial U.S. Approval: 2000prescriptionHuman PrescriptionSandoz IncMANUFACTURE2014-09-096007819314
7cea3f6aa-cd1c-4152-98bb-bbb7b977497a (view SPL)These highlights do not include all the information needed to use Argatroban Injection safely and effectively. See full prescribing information for Argatroban Injection. ARGATROBAN INJECTION in 0.9% Sodium Chloride, for intravenous infusion only Initial U.S. Approval: 2000prescriptionHuman PrescriptionSandoz Inc2011-09-2714007813285
8d4e5238f-2378-424e-bda2-f1a2cf874041 (view SPL)These highlights do not include all the information needed to use ARGATROBAN INJECTION safely and effectively. See full prescribing information for ARGATROBAN INJECTION. ARGATROBAN INJECTION, for intravenous infusion onlyInitial U.S. Approval: 2000prescriptionHuman PrescriptionPar Pharmaceutical Inc.2014-07-312420230182
9e1cf0ad0-0b23-497e-9deb-3de3bf48be44 (view SPL)These highlights do not include all the information needed to use ARGATROBAN INJECTION safely and effectively. See full prescribing information for ARGATROBAN INJECTION. Argatroban Injection, for intravenoususe only Initial U.S. Approval: 2000prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-03-161633230526
10fa216f49-0e26-4ad8-b2a2-fb7e250d2d15 (view SPL)These highlights do not include all the information needed to use Argatroban Injection safely and effectively. See full prescribing information for Argatroban Injection.ARGATROBAN INJECTION in 0.9% Sodium Chloride, for intravenous infusion onlyInitial U.S. Approval: 2014prescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-04-272007030020

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