Propranolol Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
West-Ward Pharmaceutical Corp (2015-05-20)
Oldest Current Product
2001-09-07
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\PROPRANOLOL
FDAOB
INJECTION\INJECTION\PROPRANOLOL HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\PROPRANOLOL HYDROCHLORIDE
INTRAVENOUS\INJECTION\PROPRANOLOL HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\PROPRANOLOL
INTRAVENOUS\INJECTION\PROPRANOLOL

product(s) by strength(s)

propranolol hydrochloride 1 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439872ANDAWest-Ward Pharmaceutical Corp2008-01-31PROPRANOLOL HYDROCHLORIDEINTRAVENOUSINJECTIONANDA07776091f2ff1d-68d8-4e83-a2db-618f0410ead7
2633230604ANDAApp Pharmaceuticals, Llc2001-09-07PROPRANOLOL HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA075826f14ea537-dd5c-4c78-9037-9a85e9e610ef

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840003ANDAGeneral Injecatables & Vaccines, Inc2010-08-01PROPRANOLOL HYDROCHLORIDEINTRAVENOUSINJECTION553900003ANDA0757923f412c0c-dfc2-4256-b405-dd4aa2b66e43
2525840872ANDAGeneral Injecatables & Vaccines, Inc2011-02-22PROPRANOLOL HYDROCHLORIDEINTRAVENOUSINJECTION001439872ANDA077760d197466a-c6c9-4d47-91f3-5f26b07bb943
3548683873ANDAPhysicians Total Care, Inc.2006-12-11PROPRANOLOL HYDROCHLORIDEINTRAVENOUSINJECTION001439872ANDA077760d0a8c5d1-bfc1-4829-bbf4-609e05e6d25c
4551545445ANDACardinal Health2003-02-26PROPRANOLOL HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION007813777ANDA07640087688f92-a620-437d-904a-25c19d4270c8

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070135PROPRANOLOL HYDROCHLORIDETrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1986-04-15ANDA070135_001
2ANDA070136PROPRANOLOL HYDROCHLORIDETrueSOLOPAK MEDICAL PRODUCTS INC1986-04-15ANDA070136_001
3ANDA070137PROPRANOLOL HYDROCHLORIDETrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1986-04-15ANDA070137_001
4ANDA075792PROPRANOLOL HYDROCHLORIDEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2000-08-29ANDA075792_001
5ANDA075826PROPRANOLOL HYDROCHLORIDEFRESENIUS KABI USA LLC2001-08-31ANDA075826_001
6ANDA076400PROPRANOLOL HYDROCHLORIDESANDOZ CANADA INC2003-02-26ANDA076400_001
7ANDA077760PROPRANOLOL HYDROCHLORIDEHIKMA FARMACEUTICA (PORTUGAL) SA2008-01-31ANDA077760_001
8NDA016419PROPRANOLOL HYDROCHLORIDEBAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARENDA016419_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA070135_001discontinuedPROPRANOLOL HYDROCHLORIDE (1MG/ML)INJECTIONFalse1986-04-15PROPRANOLOL HYDROCHLORIDE
2ANDA070136_001discontinuedPROPRANOLOL HYDROCHLORIDE (1MG/ML)INJECTIONFalse1986-04-15PROPRANOLOL HYDROCHLORIDE
3ANDA070137_001discontinuedPROPRANOLOL HYDROCHLORIDE (1MG/ML)INJECTIONFalse1986-04-15PROPRANOLOL HYDROCHLORIDE
4ANDA075792_001RXPROPRANOLOL HYDROCHLORIDE (1MG/ML)INJECTIONFalseAP2000-08-29PROPRANOLOL HYDROCHLORIDE
5ANDA075826_001RXPROPRANOLOL HYDROCHLORIDE (1MG/ML)INJECTIONFalseAP2001-08-31PROPRANOLOL HYDROCHLORIDE
6ANDA076400_001RXPROPRANOLOL HYDROCHLORIDE (1MG/ML)INJECTIONFalseAP2003-02-26PROPRANOLOL HYDROCHLORIDE
7ANDA077760_001RXPROPRANOLOL HYDROCHLORIDE (1MG/ML)INJECTIONFalseAP2008-01-31PROPRANOLOL HYDROCHLORIDE
8NDA016419_001RXPROPRANOLOL HYDROCHLORIDE (1MG/ML)INJECTIONTrueAPPROPRANOLOL HYDROCHLORIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13f412c0c-dfc2-4256-b405-dd4aa2b66e43 (view SPL)Propranolol HCL 1 mg/mL Injection, USP 1 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-08-261525840003
287688f92-a620-437d-904a-25c19d4270c8 (view SPL)Propranolol Hydrochloride Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-04-191551545445
391f2ff1d-68d8-4e83-a2db-618f0410ead7 (view SPL)PROPRANOLOL HYDROCHLORIDE INJECTION, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpANALYSIS, LABEL, MANUFACTURE, PACK2015-05-203001439872
4d0a8c5d1-bfc1-4829-bbf4-609e05e6d25c (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-05-271548683873
5d197466a-c6c9-4d47-91f3-5f26b07bb943 (view SPL)Propranolol Hydrochloride Injection, USP 1mg/mlprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-02-221525840872
6f14ea537-dd5c-4c78-9037-9a85e9e610ef (view SPL)Propranolol Hydrochloride Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-08-301633230604

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