Propranolol Oral Solution

Brand(s)
Hemangeol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pierre Fabre Pharmaceuticals, Inc. (2015-01-05)
Oldest Current Product
1987-05-15
License(s)
NDA, ANDA
RxNORM
ORAL SOLUTION\PROPRANOLOL
FDAOB
ORAL\SOLUTION\PROPRANOLOL HYDROCHLORIDE
SPL Active
ORAL\SOLUTION\PROPRANOLOL HYDROCHLORIDE
SPL Moiety
ORAL\SOLUTION\PROPRANOLOL

product(s) by strength(s)

propranolol hydrochloride 4 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000543727ANDARoxane Laboratories, Inc1987-05-15PROPRANOLOL HYDROCHLORIDEORALSOLUTIONANDA0709798fe0a04c-bf5b-4ba0-9df6-58c27f24b52e

propranolol hydrochloride 4.28 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1643700375HemangeolNDAPierre Fabre Pharmaceuticals, Inc.2014-04-14PROPRANOLOL HYDROCHLORIDEORALSOLUTIONNDA205410b6f9dd2a-632b-87eb-70f0-b2064d7ed48a

propranolol hydrochloride 8 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000543730ANDARoxane Laboratories, Inc1987-05-15PROPRANOLOL HYDROCHLORIDEORALSOLUTIONANDA0706908fe0a04c-bf5b-4ba0-9df6-58c27f24b52e

application(s)

#idtitledeprecatedapplicantapprovedpatentexclusivityapproved drug
1ANDA070690PROPRANOLOL HYDROCHLORIDEROXANE LABORATORIES INC1987-05-15ANDA070690_001
2ANDA070979PROPRANOLOL HYDROCHLORIDEROXANE LABORATORIES INC1987-05-15ANDA070979_001
3ANDA071984PROPRANOLOL HYDROCHLORIDETrueMORTON GROVE PHARMACEUTICALS INC1989-03-03ANDA071984_001
4ANDA071985PROPRANOLOL HYDROCHLORIDETrueMORTON GROVE PHARMACEUTICALS INC1989-03-03ANDA071985_001
5NDA205410HEMANGEOLPIERRE FABRE DERMATOLOGIE2014-03-14p8338489, METHOD TO TREAT HEMANGIOMA.NEW PRODUCT [2017-03-14]
ORPHAN DRUG EXCLUSIVITY [2021-03-14]
NDA205410_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA070690_001RXPROPRANOLOL HYDROCHLORIDE (40MG/5ML)ORALSOLUTIONTrue1987-05-15PROPRANOLOL HYDROCHLORIDE
2ANDA070979_001RXPROPRANOLOL HYDROCHLORIDE (20MG/5ML)ORALSOLUTIONTrue1987-05-15PROPRANOLOL HYDROCHLORIDE
3ANDA071984_001discontinuedPROPRANOLOL HYDROCHLORIDE (20MG/5ML)ORALSOLUTIONFalse1989-03-03PROPRANOLOL HYDROCHLORIDE
4ANDA071985_001discontinuedPROPRANOLOL HYDROCHLORIDE (40MG/5ML)ORALSOLUTIONFalse1989-03-03PROPRANOLOL HYDROCHLORIDE
5NDA205410_001RXPROPRANOLOL HYDROCHLORIDE (4.28MG/ML)ORALSOLUTIONTrue2014-03-14HEMANGEOL

patent(s)

#idexpiration dateapplication(s)
1p8338489 (view patent)2028-10-16NDA205410

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
18fe0a04c-bf5b-4ba0-9df6-58c27f24b52e (view SPL)PROPRANOLOL HYDROCHLORIDE Oral Solution20 mg per 5 mL and 40 mg per 5 mLprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2012-02-016000543727, 000543730
2b6f9dd2a-632b-87eb-70f0-b2064d7ed48a (view SPL)These highlights do not include all the information needed to use HEMANGEOL safely and effectively. See full prescribing information for HEMANGEOL. HEMANGEOL (propranolol hydrochloride oral solution) Initial U.S. Approval: 1967prescriptionHuman PrescriptionPierre Fabre Pharmaceuticals, Inc.2015-01-059643700375

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