Phentolamine Injectable Solution

Brand(s)
OraVerse
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Septodont Inc. (2011-05-16)
Oldest Current Product
1998-05-15
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\PHENTOLAMINE
FDAOB
INJECTION\INJECTION\PHENTOLAMINE MESYLATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\PHENTOLAMINE MESYLATE
SUBMUCOSAL\INJECTION, SOLUTION\PHENTOLAMINE MESYLATE
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\PHENTOLAMINE
SUBMUCOSAL\INJECTION, SOLUTION\PHENTOLAMINE

product(s) by strength(s)

phentolamine mesylate 0.235 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003620101OraVerseNDASeptodont Inc.2011-06-01PHENTOLAMINE MESYLATESUBMUCOSALINJECTION, SOLUTIONNDA0221594025cf98-ea87-4531-b0fc-6283c84f63f3

phentolamine mesylate 5 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439564ANDAWest-Ward Pharmaceutical Corp1998-05-15PHENTOLAMINE MESYLATEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONANDA040235ed6c506c-5535-4b7c-ae1a-d63f09d796c9

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA040235PHENTOLAMINE MESYLATEEUROHEALTH INTERNATIONAL SARL1998-03-11ANDA040235_001
2NDA008278REGITINENOVARTIS PHARMACEUTICALS CORPNDA008278_003
3NDA022159ORAVERSESEPTODONT HOLDING SAS2008-05-09p7569230, A METHOD OF REVERSING SOFT-TISSUE ANESTHESIA I.E. ANESTHESIA OF THE LIP AND TONGUE
p7229630, SUBSTANCE
p6872390, SUBSTANCE
p6764678, A METHOD OF REVERSING SOFT-TISSUE ANESTHESIA I.E. ANESTHESIA OF THE LIP AND TONGUE
p7575757, SUBSTANCE
NDA022159_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040235_001RXPHENTOLAMINE MESYLATE (5MG/VIAL)INJECTIONFalseAP1998-03-11PHENTOLAMINE MESYLATE
2NDA008278_003RXPHENTOLAMINE MESYLATE (5MG/VIAL)INJECTIONTrueAPREGITINE
3NDA022159_001RXPHENTOLAMINE MESYLATE (0.4MG/1.7ML)INJECTIONTrue2008-05-09ORAVERSE

patent(s)

#idexpiration dateapplication(s)
1p6764678 (view patent)2021-05-11NDA022159
2p6872390 (view patent)2021-05-11NDA022159
3p7229630 (view patent)2023-06-20NDA022159
4p7569230 (view patent)2023-10-17NDA022159
5p7575757 (view patent)2025-04-21NDA022159

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14025cf98-ea87-4531-b0fc-6283c84f63f3 (view SPL)These highlights do not include all the information needed to use OraVerse safely and effectively. See full prescribing information for OraVerse. OraVerse (phentolamine mesylate) InjectionInitial U.S. Approval: 1952prescriptionHuman PrescriptionSeptodont Inc.MANUFACTURE2011-05-161003620101
2ed6c506c-5535-4b7c-ae1a-d63f09d796c9 (view SPL)PHENTOLAMINE MESYLATE FOR INJECTION, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2015-10-053001439564

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