Protamine Sulfate (USP) Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
App Pharmaceuticals, Llc (2014-06-30)
Oldest Current Product
2000-10-18
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\PROTAMINE SULFATE (USP)
FDAOB
INJECTION\INJECTION\PROTAMINE SULFATE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\PROTAMINE SULFATE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\PROTAMINE

product(s) by strength(s)

protamine sulfate (usp) 10 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230229ANDAApp Pharmaceuticals, Llc2000-10-18PROTAMINE SULFATEINTRAVENOUSINJECTION, SOLUTIONANDA0894547a31fc4c-579f-45cc-9559-39cfad9a57b3, 8df0a819-9e1a-44ce-97a6-3ea82c867d44, e1964129-33f4-4e4e-86e3-8e6a4e65bd83

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551549391ANDACardinal Health2000-10-18PROTAMINE SULFATEINTRAVENOUSINJECTION, SOLUTION633230229ANDA089454bc755638-8797-43ab-be0b-4ea3ded3f644

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA089454PROTAMINE SULFATEFRESENIUS KABI USA LLC1987-04-07ANDA089454_001
2ANDA089474PROTAMINE SULFATETrueHIKMA MAPLE LTD1986-11-05ANDA089474_001
3ANDA089475PROTAMINE SULFATETrueHIKMA MAPLE LTD1986-11-05ANDA089475_001
4NDA006460PROTAMINE SULFATETrueELI LILLY AND CONDA006460_002
5NDA007413PROTAMINE SULFATETruePHARMACIA AND UPJOHN CONDA007413_001, NDA007413_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1ANDA089454_001RXPROTAMINE SULFATE (10MG/ML)INJECTIONTrue1987-04-07PROTAMINE SULFATE
2ANDA089474_001discontinuedPROTAMINE SULFATE (10MG/ML)INJECTIONFalse1986-11-05PROTAMINE SULFATE
3ANDA089475_001discontinuedPROTAMINE SULFATE (10MG/ML)INJECTIONFalse1986-11-05PROTAMINE SULFATE
4NDA006460_002discontinuedPROTAMINE SULFATE (10MG/ML)INJECTIONFalsePROTAMINE SULFATE
5NDA007413_001discontinuedPROTAMINE SULFATE (50MG/VIAL)INJECTIONFalsePROTAMINE SULFATE
6NDA007413_002discontinuedPROTAMINE SULFATE (250MG/VIAL)INJECTIONFalse1984-08-02PROTAMINE SULFATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
17a31fc4c-579f-45cc-9559-39cfad9a57b3 (view SPL)Protamine Sulfate Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-05-161633230229
28df0a819-9e1a-44ce-97a6-3ea82c867d44 (view SPL)Protamine Sulfate Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-06-301633230229
3bc755638-8797-43ab-be0b-4ea3ded3f644 (view SPL)Protamine Sulfate Injection USPprescriptionHuman PrescriptionCardinal HealthREPACK2015-01-212551549391
4e1964129-33f4-4e4e-86e3-8e6a4e65bd83 (view SPL)Protamine Sulfate Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-06-302633230229

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