Buprenorphine Cartridge

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2009-12-14)
Oldest Current Product
2010-07-12
License(s)
ANDA
RxNORM
CARTRIDGE\BUPRENORPHINE
FDAOB
INJECTION\INJECTION\BUPRENORPHINE HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\BUPRENORPHINE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\BUPRENORPHINE

product(s) by strength(s)

1 ml buprenorphine 0.3 mg/ml cartridge

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004092012ANDAHospira, Inc.2010-07-12BUPRENORPHINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA07413723aa1bb3-cecf-4e62-29bb-48488bb66fc3

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950515ANDARebel Distributors Corp2010-07-12BUPRENORPHINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004092012ANDA0741376795ade9-e06e-4daa-bb45-821901a055f5

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1ANDA074137BUPRENORPHINE HYDROCHLORIDEHOSPIRA INC1996-06-03ANDA074137_001Buprenorphine Injectable Solution
2ANDA076931BUPRENORPHINE HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL2005-03-02ANDA076931_001Buprenorphine Injectable Solution
3ANDA078331BUPRENORPHINE HYDROCHLORIDELUITPOLD PHARMACEUTICALS INC2007-03-27ANDA078331_001Buprenorphine Injectable Solution
4ANDA206586BUPRENORPHINE HYDROCHLORIDEPAR STERILE PRODUCTS LLC2015-07-28ANDA206586_001Buprenorphine Injectable Solution
5NDA018401BUPRENEXINDIVIOR INCNDA018401_001Buprenorphine Injectable Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA074137_001RXBUPRENORPHINE HYDROCHLORIDE (EQ 0.3MG BASE/ML)INJECTIONFalseAP1996-06-03BUPRENORPHINE HYDROCHLORIDE
2ANDA076931_001RXBUPRENORPHINE HYDROCHLORIDE (EQ 0.3MG BASE/ML)INJECTIONFalseAP2005-03-02BUPRENORPHINE HYDROCHLORIDE
3ANDA078331_001RXBUPRENORPHINE HYDROCHLORIDE (EQ 0.3MG BASE/ML)INJECTIONFalseAP2007-03-27BUPRENORPHINE HYDROCHLORIDE
4ANDA206586_001RXBUPRENORPHINE HYDROCHLORIDE (EQ 0.3MG BASE/ML)INJECTIONFalseAP2015-07-28BUPRENORPHINE HYDROCHLORIDE
5NDA018401_001RXBUPRENORPHINE HYDROCHLORIDE (EQ 0.3MG BASE/ML)INJECTIONTrueAPBUPRENEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
123aa1bb3-cecf-4e62-29bb-48488bb66fc3 (view SPL)BuprenorphineHydrochlorideInjectionprescriptionHuman PrescriptionHospira, Inc.2009-12-1410004092012
26795ade9-e06e-4daa-bb45-821901a055f5 (view SPL)BuprenorphineHydrochlorideInjectionprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-101216950515

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