Alprostadil Cartridge

Brand(s)
Edex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Actient Pharmaceuticals, Llc (2015-03-24)
Oldest Current Product
2012-01-15
License(s)
NDA
RxNORM
CARTRIDGE\ALPROSTADIL
FDAOB
INJECTION\INJECTION\ALPROSTADIL\rdfq
SPL Active
INTRACAVERNOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ALPROSTADIL
SPL Moiety
INTRACAVERNOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ALPROSTADIL

product(s) by strength(s)

1 ml alprostadil 0.01 mg/ml cartridge

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1522440010EdexNDAActient Pharmaceuticals, Llc2012-04-15ALPROSTADILINTRACAVERNOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA020649e8b8ec8d-1318-43e4-a182-446e9f9579de

1 ml alprostadil 0.02 mg/ml cartridge

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1522440020EdexNDAActient Pharmaceuticals, Llc2012-01-15ALPROSTADILINTRACAVERNOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA020649e8b8ec8d-1318-43e4-a182-446e9f9579de

1 ml alprostadil 0.04 mg/ml cartridge

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1522440040EdexNDAActient Pharmaceuticals, Llc2012-03-15ALPROSTADILINTRACAVERNOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA020649e8b8ec8d-1318-43e4-a182-446e9f9579de

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drugin other drug docs
1ANDA074815ALPROSTADILEUROHEALTH INTERNATIONAL SARL1998-01-20ANDA074815_001Alprostadil Injection
Alprostadil Prefilled Syringe
2ANDA075196ALPROSTADILTEVA PHARMACEUTICALS USA1999-04-30ANDA075196_001Alprostadil Injection
Alprostadil Prefilled Syringe
3NDA018484PROSTIN VR PEDIATRICPHARMACIA AND UPJOHN CONDA018484_001Alprostadil Injection
Alprostadil Prefilled Syringe
4NDA020379CAVERJECTPHARMACIA AND UPJOHN CO1995-07-06p5741523NDA020379_001, NDA020379_002, NDA020379_003, NDA020379_004Alprostadil Injection
Alprostadil Prefilled Syringe
5NDA020649EDEXAUXILIUM PHARMACEUTICALS LLC1997-06-12NDA020649_001, NDA020649_002, NDA020649_003, NDA020649_004, NDA020649_005, NDA020649_006, NDA020649_007Alprostadil Injection
Alprostadil Prefilled Syringe
6NDA020755CAVERJECTTruePFIZER INC1997-10-01NDA020755_001, NDA020755_002, NDA020755_003Alprostadil Injection
Alprostadil Prefilled Syringe
7NDA021212CAVERJECT IMPULSEPHARMACIA AND UPJOHN CO2002-06-11p5716338, SUBSTANCENDA021212_001, NDA021212_002Alprostadil Injection
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 Injection
Somatropin Injectable Solution
Alprostadil Prefilled Syringe
Somatropin Prefilled Syringe
2p5741523 (view patent)2015-04-21NDA020379Alprostadil Injection
Alprostadil Prefilled Syringe

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1e8b8ec8d-1318-43e4-a182-446e9f9579de (view SPL)edex (alprostadil for injection)prescriptionHuman PrescriptionActient Pharmaceuticals, LlcANALYSIS, MANUFACTURE2015-03-242522440010, 522440020, 522440040

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