Dalteparin Injectable Solution

Brand(s)
Fragmin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Labs (2015-07-02)
Oldest Current Product
1994-12-22
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\DALTEPARIN
FDAOB
INJECTION\INJECTION\DALTEPARIN SODIUM\rdfq
SUBCUTANEOUS\INJECTION\DALTEPARIN SODIUM
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\DALTEPARIN SODIUM
SUBCUTANEOUS\INJECTION\DALTEPARIN SODIUM
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\DALTEPARIN
SUBCUTANEOUS\INJECTION\DALTEPARIN

product(s) by strength(s)

dalteparin sodium 10000 unt/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1628560102FragminNDAEisai Inc.1994-12-22DALTEPARIN SODIUMSUBCUTANEOUSINJECTION, SOLUTIONNDA020287c5cd4a8e-14c0-440b-b453-9f3d3250c951

dalteparin sodium 25000 unt/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690232FragminNDAPfizer Labs2015-04-01DALTEPARIN SODIUMSUBCUTANEOUSINJECTIONNDA02028723527b8b-9b28-4e6d-9751-33b143975ac7

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1NDA020287FRAGMINPFIZER INC1994-12-22NDA020287_001, NDA020287_002, NDA020287_003, NDA020287_004, NDA020287_005, NDA020287_006, NDA020287_007, NDA020287_008, NDA020287_009, NDA020287_010, NDA020287_011Dalteparin Prefilled Syringe

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020287_001RXDALTEPARIN SODIUM (2,500IU/0.2ML)SUBCUTANEOUSINJECTIONFalse1994-12-22FRAGMIN
2NDA020287_002discontinuedDALTEPARIN SODIUM (10,000IU/0.4ML)SUBCUTANEOUSINJECTIONFalse2007-05-01FRAGMIN
3NDA020287_003RXDALTEPARIN SODIUM (5,000IU/0.2ML)SUBCUTANEOUSINJECTIONFalse1996-03-18FRAGMIN
4NDA020287_004RXDALTEPARIN SODIUM (10,000IU/ML)SUBCUTANEOUSINJECTIONFalse1998-01-30FRAGMIN
5NDA020287_005RXDALTEPARIN SODIUM (7,500IU/0.3ML)SUBCUTANEOUSINJECTIONFalse2002-04-04FRAGMIN
6NDA020287_006RXDALTEPARIN SODIUM (95,000IU/3.8ML)SUBCUTANEOUSINJECTIONTrue2002-04-04FRAGMIN
7NDA020287_007discontinuedDALTEPARIN SODIUM (95,000IU/9.5ML)SUBCUTANEOUSINJECTIONFalse2002-04-04FRAGMIN
8NDA020287_008discontinuedDALTEPARIN SODIUM (7,500 IU/0.75ML)INJECTIONFalse2002-04-04FRAGMIN
9NDA020287_009RXDALTEPARIN SODIUM (12,500IU/0.5ML)SUBCUTANEOUSINJECTIONFalse2007-05-01FRAGMIN
10NDA020287_010RXDALTEPARIN SODIUM (15,000IU/0.6ML)SUBCUTANEOUSINJECTIONFalse2007-05-01FRAGMIN
11NDA020287_011RXDALTEPARIN SODIUM (18,000IU/0.72ML)SUBCUTANEOUSINJECTIONFalse2007-05-01FRAGMIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
123527b8b-9b28-4e6d-9751-33b143975ac7 (view SPL)These highlights do not include all the information needed to use FRAGMIN safely and effectively. See full prescribing information for FRAGMIN. FRAGMIN (dalteparin sodium) Injection, for subcutaneous useInitial U.S. Approval: 1994prescriptionHuman PrescriptionPfizer Labs2015-07-024000690232, 000690195, 000690196, 000690206, 000690217, 000690220, 000690223, 000690228Dalteparin Prefilled Syringe
2c5cd4a8e-14c0-440b-b453-9f3d3250c951 (view SPL)These highlights do not include all the information needed to use FRAGMIN safely and effectively. See full prescribing information for FRAGMIN. FRAGMIN (dalteparin sodium injection) for Subcutaneous Use Only Initial U.S. Approval: 1994prescriptionHuman PrescriptionEisai Inc.API MANUFACTURE, MANUFACTURE2015-01-3113628560102, 628560100, 628560101, 628560125, 628560150, 628560180, 628560250, 628560251, 628560500, 628560750Dalteparin Prefilled Syringe

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