Carteolol Ophthalmic Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bausch & Lomb Incorporated (2013-11-04)
Oldest Current Product
2000-01-05
License(s)
ANDA
RxNORM
OPHTHALMIC SOLUTION\CARTEOLOL
FDAOB
OPHTHALMIC\SOLUTION_DROPS\CARTEOLOL HYDROCHLORIDE
SPL Active
OPHTHALMIC\SOLUTION/DROPS\CARTEOLOL HYDROCHLORIDE
OPHTHALMIC\SOLUTION\CARTEOLOL HYDROCHLORIDE
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\CARTEOLOL
OPHTHALMIC\SOLUTION\CARTEOLOL

product(s) by strength(s)

carteolol hydrochloride 10 mg/ml ophthalmic solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1242080367ANDABausch & Lomb Incorporated2000-01-20CARTEOLOL HYDROCHLORIDEOPHTHALMICSOLUTION/DROPSANDA075546eccd10e3-ec28-4ab0-887f-fce616cf1bc2
2613140238ANDASandoz Inc2000-01-05CARTEOLOL HYDROCHLORIDEOPHTHALMICSOLUTIONANDA075476571fe550-399d-4296-835c-37aa1ab9b409

relabeler product(s)(s)

#idlabeleractive ingredient(s)routedose formequivalent productspl
1458650859Medsource PharmaceuticalsCARTEOLOL HYDROCHLORIDEOPHTHALMICSOLUTION/DROPS24208036720c699bc-0cea-5984-e054-00144ff88e88

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075476CARTEOLOL HYDROCHLORIDEALCON LABORATORIES INC2000-01-03ANDA075476_001
2ANDA075546CARTEOLOL HYDROCHLORIDEBAUSCH AND LOMB INC2000-01-20ANDA075546_001
3ANDA076097CARTEOLOL HYDROCHLORIDETrueAPOTEX INC2002-02-06ANDA076097_001
4NDA019972OCUPRESSNOVARTIS PHARMACEUTICALS CORP1990-05-23NDA019972_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075476_001RXCARTEOLOL HYDROCHLORIDE (1%)OPHTHALMICSOLUTION/DROPSFalseAT2000-01-03CARTEOLOL HYDROCHLORIDE
2ANDA075546_001RXCARTEOLOL HYDROCHLORIDE (1%)OPHTHALMICSOLUTION/DROPSFalseAT2000-01-20CARTEOLOL HYDROCHLORIDE
3ANDA076097_001discontinuedCARTEOLOL HYDROCHLORIDE (1%)OPHTHALMICSOLUTION/DROPSFalse2002-02-06CARTEOLOL HYDROCHLORIDE
4NDA019972_001RXCARTEOLOL HYDROCHLORIDE (1%)OPHTHALMICSOLUTION/DROPSTrueAT1990-05-23OCUPRESS

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
120c699bc-0cea-5984-e054-00144ff88e88 (view SPL)Carteolol Hydrochloride Ophthalmic Solution USP, 1% (Sterile)prescriptionHuman PrescriptionMedsource Pharmaceuticalsrelabel2015-09-271458650859
2571fe550-399d-4296-835c-37aa1ab9b409 (view SPL)Carteolol Hydrochloride Ophthalmic Solution USP, 1% Rx Only SterileprescriptionHuman PrescriptionSandoz IncMANUFACTURE2012-03-073613140238
3eccd10e3-ec28-4ab0-887f-fce616cf1bc2 (view SPL)Carteolol Hydrochloride Ophthalmic Solution USP, 1% (Sterile)prescriptionHuman PrescriptionBausch & Lomb IncorporatedAPI MANUFACTURE, MANUFACTURE2013-11-046242080367

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