Flurbiprofen Ophthalmic Solution

Brand(s)
Ocufen
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Allergan, Inc. (2012-01-03)
Oldest Current Product
1987-01-01
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
OPHTHALMIC SOLUTION\FLURBIPROFEN
FDAOB
OPHTHALMIC\SOLUTION_DROPS\FLURBIPROFEN SODIUM
SPL Active
OPHTHALMIC\SOLUTION/DROPS\FLURBIPROFEN SODIUM
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\FLURBIPROFEN

product(s) by strength(s)

flurbiprofen sodium 0.3 mg/ml ophthalmic solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1119800801OcufenNDAAllergan, Inc.1987-01-01FLURBIPROFEN SODIUMOPHTHALMICSOLUTION/DROPSNDA0194045a4d5684-b20a-4fde-a808-404c7b9d25b3

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1242080314ANDABausch & Lomb Incorporated1995-01-04FLURBIPROFEN SODIUMOPHTHALMICSOLUTION/DROPSANDA07444711db354f-caf9-4567-811e-6c9beb1330c7
2607580910NDA AUTHORIZED GENERICPacific Pharma, Inc.1997-05-29FLURBIPROFEN SODIUMOPHTHALMICSOLUTION/DROPSNDA0194041c7a0afe-fb85-4e4e-9f04-979b00bbb077

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950615ANDARebel Distributors Corp1995-01-04FLURBIPROFEN SODIUMOPHTHALMICSOLUTION/DROPS242080314ANDA074447725fb4ac-3bd2-4c0f-829f-a3a40863ebce
2422540023NDA AUTHORIZED GENERICRebel Distributors Corp1997-05-29FLURBIPROFEN SODIUMOPHTHALMICSOLUTION/DROPS607580910NDA019404043665e5-c6e0-4353-9933-6ba9e4860842

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA074447FLURBIPROFEN SODIUMBAUSCH AND LOMB INC1995-01-04ANDA074447_001
2NDA019404OCUFENALLERGAN PHARMACEUTICAL1986-12-31NDA019404_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074447_001RXFLURBIPROFEN SODIUM (0.03%)OPHTHALMICSOLUTION/DROPSFalseAT1995-01-04FLURBIPROFEN SODIUM
2NDA019404_001RXFLURBIPROFEN SODIUM (0.03%)OPHTHALMICSOLUTION/DROPSTrueAT1986-12-31OCUFEN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1043665e5-c6e0-4353-9933-6ba9e4860842 (view SPL)Flurbiprofen SodiumOphthalmic Solution, USP 0.03%prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-12-131422540023
211db354f-caf9-4567-811e-6c9beb1330c7 (view SPL)Flurbiprofen Sodium Ophthalmic Solution USP, 0.03% (Sterile)prescriptionHuman PrescriptionBausch & Lomb IncorporatedMANUFACTURE2012-12-184242080314
31c7a0afe-fb85-4e4e-9f04-979b00bbb077 (view SPL)Flurbiprofen SodiumOphthalmic Solution, USP 0.03%prescriptionHuman PrescriptionPacific Pharma, Inc.MANUFACTURE2014-04-233607580910
45a4d5684-b20a-4fde-a808-404c7b9d25b3 (view SPL)OCUFEN (flurbiprofen sodium ophthalmic solution, USP) 0.03%prescriptionHuman PrescriptionAllergan, Inc.MANUFACTURE2012-01-036119800801
5725fb4ac-3bd2-4c0f-829f-a3a40863ebce (view SPL)Flurbiprofen Sodium Ophthalmic Solution USP, 0.03%prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-281216950615

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