Enalaprilat Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2015-10-19)
Oldest Current Product
2000-08-22
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\ENALAPRILAT
FDAOB
INJECTION\INJECTION\ENALAPRILAT\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\ENALAPRILAT
INTRAVENOUS\INJECTION\ENALAPRILAT
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\ENALAPRILAT ANHYDROUS
INTRAVENOUS\INJECTION\ENALAPRILAT
INTRAVENOUS\INJECTION\ENALAPRILAT ANHYDROUS

product(s) by strength(s)

enalaprilat 1.25 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439786ANDAWest-Ward Pharmaceutical Corp2008-12-23ENALAPRILATINTRAVENOUSINJECTIONANDA078687eabae489-e254-4987-ab90-7cda20a6f856
2001439787ANDAWest-Ward Pharmaceutical Corp2008-12-23ENALAPRILATINTRAVENOUSINJECTIONANDA078687eabae489-e254-4987-ab90-7cda20a6f856
3004092122ANDAHospira, Inc.2000-08-22, 2005-04-30ENALAPRILATINTRAVENOUSINJECTION, SOLUTIONANDA075458c4d98e3c-bd7d-4076-be9e-00b98cf36935, d3d573a7-50d5-46a8-9f92-baad3ae0831e
4007038401ANDATeva Parenteral Medicines, Inc2005-10-06ENALAPRILATINTRAVENOUSINJECTION, SOLUTIONANDA075578b59da9a8-0fd0-42eb-8e95-1ce9a0fd6372
5007038411ANDATeva Parenteral Medicines, Inc2005-10-06ENALAPRILATINTRAVENOUSINJECTION, SOLUTIONANDA075578b59da9a8-0fd0-42eb-8e95-1ce9a0fd6372

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551540355ANDACardinal Health2000-08-23ENALAPRILATINTRAVENOUSINJECTION553900010ANDA075634f5d3b22e-5067-4c21-bea5-23acae12d2df

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075456ENALAPRILATTrueHOSPIRA INC2000-08-22ANDA075456_001
2ANDA075458ENALAPRILATHOSPIRA INC2000-08-22ANDA075458_001
3ANDA075571ENALAPRILATTrueHOSPIRA INC2000-08-22ANDA075571_001
4ANDA075578ENALAPRILATTEVA PHARMACEUTICALS USA2000-08-22ANDA075578_001
5ANDA075634ENALAPRILATBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2000-08-22ANDA075634_001
6ANDA078687ENALAPRILATHIKMA FARMACEUTICA (PORTUGAL) SA2008-12-23ANDA078687_001
7NDA019309VASOTECTrueBIOVAIL LABORATORIES INTERNATIONAL SRL1988-02-09NDA019309_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA075456_001discontinuedENALAPRILAT (1.25MG/ML)INJECTIONFalse2000-08-22ENALAPRILAT
2ANDA075458_001RXENALAPRILAT (1.25MG/ML)INJECTIONTrueAP2000-08-22ENALAPRILAT
3ANDA075571_001discontinuedENALAPRILAT (1.25MG/ML)INJECTIONFalse2000-08-22ENALAPRILAT
4ANDA075578_001RXENALAPRILAT (1.25MG/ML)INJECTIONFalseAP2000-08-22ENALAPRILAT
5ANDA075634_001RXENALAPRILAT (1.25MG/ML)INJECTIONTrueAP2000-08-22ENALAPRILAT
6ANDA078687_001RXENALAPRILAT (1.25MG/ML)INJECTIONFalseAP2008-12-23ENALAPRILAT
7NDA019309_001discontinuedENALAPRILAT (1.25MG/ML)INJECTIONFalse1988-02-09VASOTEC

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1b59da9a8-0fd0-42eb-8e95-1ce9a0fd6372 (view SPL)Enalaprilat Injection USP84018411prescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-06-085007038401, 007038411
2c4d98e3c-bd7d-4076-be9e-00b98cf36935 (view SPL)Enalaprilat Injection, USPprescriptionHuman PrescriptionHospira, Inc.2015-10-1913004092122
3d3d573a7-50d5-46a8-9f92-baad3ae0831e (view SPL)Enalaprilat Injection, USPprescriptionHuman PrescriptionHospira, Inc.2015-10-192004092122
4eabae489-e254-4987-ab90-7cda20a6f856 (view SPL)Enalaprilat Injection, USP Rx OnlyprescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2011-09-283001439786, 001439787
5f5d3b22e-5067-4c21-bea5-23acae12d2df (view SPL)ENALAPRILAT INJECTIONprescriptionHuman PrescriptionCardinal HealthREPACK2012-08-062551540355

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