Alprostadil Injection

Brand(s)
Caverject, Prostin VR
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2015-10-08)
Oldest Current Product
1981-10-16
License(s)
NDA, ANDA
RxNORM
INJECTION\ALPROSTADIL
FDAOB
INJECTION\INJECTION\ALPROSTADIL\rdfq
SPL Active
INTRACAVERNOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ALPROSTADIL
INTRAVASCULAR\INJECTION, SOLUTION\ALPROSTADIL
INTRAVASCULAR\INJECTION\ALPROSTADIL
SPL Moiety
INTRACAVERNOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ALPROSTADIL
INTRAVASCULAR\INJECTION, SOLUTION\ALPROSTADIL
INTRAVASCULAR\INJECTION\ALPROSTADIL

product(s) by strength(s)

alprostadil 0.005 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000095131CaverjectNDAPharmacia And Upjohn Company1995-07-06ALPROSTADILINTRACAVERNOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA020379a295fc1e-d82c-4f44-bc2d-a552bf594c98

alprostadil 0.01 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000093778CaverjectNDAPharmacia And Upjohn Company1995-07-06ALPROSTADILINTRACAVERNOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA020379a295fc1e-d82c-4f44-bc2d-a552bf594c98

alprostadil 0.02 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000093701CaverjectNDAPharmacia And Upjohn Company1995-07-06ALPROSTADILINTRACAVERNOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA020379a295fc1e-d82c-4f44-bc2d-a552bf594c98

alprostadil 0.04 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000097686CaverjectNDAPharmacia And Upjohn Company1995-07-06ALPROSTADILINTRACAVERNOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA020379a295fc1e-d82c-4f44-bc2d-a552bf594c98

1 ml alprostadil 0.5 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000093169Prostin VRNDAPharmacia And Upjohn Company1981-10-16ALPROSTADILINTRAVASCULARINJECTION, SOLUTIONNDA018484dea460fa-d05e-4191-8461-f185a711ad89

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007031501ANDATeva Parenteral Medicines, Inc1999-04-30ALPROSTADILINTRAVASCULARINJECTIONANDA075196bb155759-3889-4cb3-9695-42a588f4f689

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drugin other drug docs
1ANDA074815ALPROSTADILEUROHEALTH INTERNATIONAL SARL1998-01-20ANDA074815_001Alprostadil Cartridge
Alprostadil Prefilled Syringe
2ANDA075196ALPROSTADILTEVA PHARMACEUTICALS USA1999-04-30ANDA075196_001Alprostadil Cartridge
Alprostadil Prefilled Syringe
3NDA018484PROSTIN VR PEDIATRICPHARMACIA AND UPJOHN CONDA018484_001Alprostadil Cartridge
Alprostadil Prefilled Syringe
4NDA020379CAVERJECTPHARMACIA AND UPJOHN CO1995-07-06p5741523NDA020379_001, NDA020379_002, NDA020379_003, NDA020379_004Alprostadil Cartridge
Alprostadil Prefilled Syringe
5NDA020649EDEXAUXILIUM PHARMACEUTICALS LLC1997-06-12NDA020649_001, NDA020649_002, NDA020649_003, NDA020649_004, NDA020649_005, NDA020649_006, NDA020649_007Alprostadil Cartridge
Alprostadil Prefilled Syringe
6NDA020755CAVERJECTTruePFIZER INC1997-10-01NDA020755_001, NDA020755_002, NDA020755_003Alprostadil Cartridge
Alprostadil Prefilled Syringe
7NDA021212CAVERJECT IMPULSEPHARMACIA AND UPJOHN CO2002-06-11p5716338, SUBSTANCENDA021212_001, NDA021212_002Alprostadil Cartridge
Alprostadil Prefilled Syringe

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA074815_001RXALPROSTADIL (0.5MG/ML)INJECTIONFalseAP1998-01-20ALPROSTADIL
2ANDA075196_001RXALPROSTADIL (0.5MG/ML)INJECTIONFalseAP1999-04-30ALPROSTADIL
3NDA018484_001RXALPROSTADIL (0.5MG/ML)INJECTIONTrueAPPROSTIN VR PEDIATRIC
4NDA020379_001RXALPROSTADIL (0.01MG/VIAL)INJECTIONFalseAP1995-07-06CAVERJECT
5NDA020379_002RXALPROSTADIL (0.02MG/VIAL)INJECTIONTrueAP1995-07-06CAVERJECT
6NDA020379_003RXALPROSTADIL (0.005MG/VIAL)INJECTIONFalse1996-06-27CAVERJECT
7NDA020379_004RXALPROSTADIL (0.04MG/VIAL)INJECTIONTrueAP1997-05-19CAVERJECT
8NDA020649_001discontinuedALPROSTADIL (0.005MG/VIAL)INJECTIONFalse1997-06-12EDEX
9NDA020649_002RXALPROSTADIL (0.01MG/VIAL)INJECTIONFalseAP1997-06-12EDEX
10NDA020649_003RXALPROSTADIL (0.02MG/VIAL)INJECTIONFalseAP1997-06-12EDEX
11NDA020649_004RXALPROSTADIL (0.04MG/VIAL)INJECTIONTrueAP1997-06-12EDEX
12NDA020649_005RXALPROSTADIL (0.01MG/VIAL)INJECTIONTrue1998-07-30EDEX
13NDA020649_006RXALPROSTADIL (0.02MG/VIAL)INJECTIONTrue1998-07-30EDEX
14NDA020649_007RXALPROSTADIL (0.04MG/VIAL)INJECTIONTrue1998-07-30EDEX
15NDA020755_001discontinuedALPROSTADIL (0.005MG/ML)INJECTIONFalse1997-10-31CAVERJECT
16NDA020755_002discontinuedALPROSTADIL (0.01MG/ML)INJECTIONFalse1997-10-01CAVERJECT
17NDA020755_003discontinuedALPROSTADIL (0.02MG/ML)INJECTIONFalse1997-10-01CAVERJECT
18NDA021212_001RXALPROSTADIL (0.01MG/VIAL)INJECTIONFalse2002-06-11CAVERJECT IMPULSE
19NDA021212_002RXALPROSTADIL (0.02MG/VIAL)INJECTIONFalse2002-06-11CAVERJECT IMPULSE

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5716338 (view patent)2015-02-10NDA021212, NDA020280Alprostadil Cartridge
Somatropin Injectable Solution
Alprostadil Prefilled Syringe
Somatropin Prefilled Syringe
2p5741523 (view patent)2015-04-21NDA020379Alprostadil Cartridge
Alprostadil Prefilled Syringe

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a295fc1e-d82c-4f44-bc2d-a552bf594c98 (view SPL)Caverject alprostadil for injectionprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-10-086000093701, 000093778, 000095131, 000097686
2bb155759-3889-4cb3-9695-42a588f4f689 (view SPL)Alprostadil Injection, USPprescriptionHuman PrescriptionTeva Parenteral Medicines, IncMANUFACTURE2009-10-091007031501
3dea460fa-d05e-4191-8461-f185a711ad89 (view SPL)Prostin VR Pediatric alprostadil injection, USPprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-07-307000093169

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