Dihematoporphyrin Ether Injectable Solution

Brand(s)
Photofrin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pinnacle Biologics, Inc. (2015-03-31)
Oldest Current Product
1995-12-27
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\DIHEMATOPORPHYRIN ETHER
FDAOB
INJECTION\INJECTION\PORFIMER SODIUM\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\PORFIMER SODIUM
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\PORFIMER

product(s) by strength(s)

dihematoporphyrin ether 2.5 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1761280155PhotofrinNDAPinnacle Biologics, Inc.1995-12-27PORFIMER SODIUMINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONNDA0204515c4841b4-fbc0-4163-8ee1-cb28629cbfbf

application(s)

#idtitleapplicantapprovedapproved drug
1NDA020451PHOTOFRINCONCORDIA LABORATORIES INC1995-12-27NDA020451_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA020451_001RXPORFIMER SODIUM (75MG/VIAL)INJECTIONFalse1995-12-27PHOTOFRIN

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
15c4841b4-fbc0-4163-8ee1-cb28629cbfbf (view SPL)These highlights do not include all the information needed to use PHOTOFRIN safely and effectively. See full prescribing information for PHOTOFRIN. PHOTOFRIN (porfimer sodium) INJECTIONInitial U.S. Approval: 1995prescriptionHuman PrescriptionPinnacle Biologics, Inc.2015-03-314761280155

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