Cisplatin Injectable Solution

Brand(s)
Platinol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
App Pharmaceuticals, Llc (2013-09-19)
Oldest Current Product
2000-06-01
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\CISPLATIN
FDAOB
INJECTION\INJECTION\CISPLATIN\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\CISPLATIN
INTRAVENOUS\INJECTION\CISPLATIN
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\CISPLATIN
INTRAVENOUS\INJECTION\CISPLATIN

product(s) by strength(s)

cisplatin 1 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1445670509NDAWg Critical Care, Llc2012-01-13CISPLATININTRAVENOUSINJECTION, SOLUTIONNDA0180572bf8d2fb-80c8-401d-8e9b-d58463f5e954
2445670510NDAWg Critical Care, Llc2012-01-13CISPLATININTRAVENOUSINJECTION, SOLUTIONNDA0180572bf8d2fb-80c8-401d-8e9b-d58463f5e954
3611260004PlatinolNDACorden Pharma Latina S.P.A.2012-01-13CISPLATININTRAVENOUSINJECTION, SOLUTIONNDA018057a043dd33-3d1d-4884-bb75-80f221e749ba

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690084ANDAPfizer Labs2012-04-19CISPLATININTRAVENOUSINJECTIONANDA091062199a6ab3-9b00-49fc-90d4-644d58141235
2007035747ANDATeva Parenteral Medicines, Inc2000-06-01CISPLATININTRAVENOUSINJECTION, SOLUTIONANDA074656a440f077-46f6-4688-a209-65bce38d1c92
3007035748ANDATeva Parenteral Medicines, Inc2000-06-01CISPLATININTRAVENOUSINJECTION, SOLUTIONANDA074656a440f077-46f6-4688-a209-65bce38d1c92
4633230103ANDAApp Pharmaceuticals, Llc2000-09-05CISPLATININTRAVENOUSINJECTION, SOLUTIONANDA074735de6302d5-85f0-4116-a709-57826c2c84fe
5674570425ANDAMylan Institutional Llc2012-04-19CISPLATININTRAVENOUSINJECTIONANDA09106264975f5d-0eca-4998-8a72-06eec98285eb

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074656CISPLATINPHARMACHEMIE BV2000-05-16ANDA074656_001
2ANDA074713CISPLATINTrueBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2000-11-14ANDA074713_001, ANDA074713_002
3ANDA074735CISPLATINFRESENIUS KABI USA LLC1999-07-16ANDA074735_001
4ANDA074814CISPLATINTrueTEVA PHARMACEUTICALS USA2000-05-16ANDA074814_001
5ANDA075036CISPLATINEUROHEALTH INTERNATIONAL SARL2000-11-07ANDA075036_001
6ANDA091062CISPLATINMYLAN LABORATORIES LTD2012-04-18ANDA091062_001
7ANDA206774CISPLATINACCORD HEALTHCARE INC2015-08-18ANDA206774_001
8NDA018057CISPLATINHQ SPECIALTY PHARMA CORPNDA018057_001, NDA018057_002, NDA018057_003, NDA018057_004

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA074656_001RXCISPLATIN (1MG/ML)INJECTIONFalseAP2000-05-16CISPLATIN
2ANDA074713_001discontinuedCISPLATIN (10MG/VIAL)INJECTIONFalse2000-11-14CISPLATIN
3ANDA074713_002discontinuedCISPLATIN (50MG/VIAL)INJECTIONFalse2000-11-14CISPLATIN
4ANDA074735_001RXCISPLATIN (1MG/ML)INJECTIONTrueAP1999-07-16CISPLATIN
5ANDA074814_001discontinuedCISPLATIN (1MG/ML)INJECTIONFalse2000-05-16CISPLATIN
6ANDA075036_001RXCISPLATIN (1MG/ML)INJECTIONFalseAP2000-11-07CISPLATIN
7ANDA091062_001RXCISPLATIN (1MG/ML)INJECTIONFalseAP2012-04-18CISPLATIN
8ANDA206774_001RXCISPLATIN (1MG/ML)INJECTIONFalseAP2015-08-18CISPLATIN
9NDA018057_001discontinuedCISPLATIN (10MG/VIAL)INJECTIONFalseCISPLATIN
10NDA018057_002discontinuedCISPLATIN (50MG/VIAL)INJECTIONFalseCISPLATIN
11NDA018057_003discontinuedCISPLATIN (0.5MG/ML)INJECTIONFalse1984-07-18CISPLATIN
12NDA018057_004RXCISPLATIN (1MG/ML)INJECTIONFalseAP1988-11-08CISPLATIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1199a6ab3-9b00-49fc-90d4-644d58141235 (view SPL)Cisplatin InjectionprescriptionHuman PrescriptionPfizer LabsAnalysis, Manufacture, Pack, Sterilize2012-04-211000690084
22bf8d2fb-80c8-401d-8e9b-d58463f5e954 (view SPL)CISplatin InjectionprescriptionHuman PrescriptionWg Critical Care, Llc2015-04-153445670509, 445670510, 445670511
364975f5d-0eca-4998-8a72-06eec98285eb (view SPL)Cisplatin InjectionprescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2014-01-101674570425
4a043dd33-3d1d-4884-bb75-80f221e749ba (view SPL)PLATINOL-AQ (cisplatin injection)prescriptionHuman PrescriptionCorden Pharma Latina S.P.A.MANUFACTURE2012-01-133611260004
5a440f077-46f6-4688-a209-65bce38d1c92 (view SPL)CISplatin InjectionprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-10-307007035747, 007035748
6b2a8e240-5e93-4a58-9ba2-688a87a5e20c (view SPL)PLATINOL (cisplatin for injection, USP)prescriptionHuman PrescriptionCorden Pharma Latina S.P.A.MANUFACTURE2012-01-134611260003
7de6302d5-85f0-4116-a709-57826c2c84fe (view SPL)Cisplatin InjectionprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2013-09-193633230103

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