prednisolone / Sulfacetamide Ophthalmic Ointment

Brand(s)
Blephamide
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Allergan, Inc. (2014-03-07)
Oldest Current Product
1987-01-01
License(s)
ANDA
RxNORM
OPHTHALMIC OINTMENT\PREDNISOLONE:SULFACETAMIDE
FDAOB
OPHTHALMIC\OINTMENT\PREDNISOLONE ACETATE: SULFACETAMIDE SODIUM
OPHTHALMIC\SUSPENSION_DROPS\PREDNISOLONE ACETATE: SULFACETAMIDE SODIUM
SPL Active
OPHTHALMIC\OINTMENT\PREDNISOLONE ACETATE: SULFACETAMIDE SODIUM
SPL Moiety
OPHTHALMIC\OINTMENT\PREDNISOLONE: SULFACETAMIDE

product(s) by strength(s)

prednisolone acetate 0.002 mg/mg / sulfacetamide sodium 0.1 mg/mg ophthalmic ointment

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000230313BlephamideANDAAllergan, Inc.1987-01-01PREDNISOLONE ACETATE, SULFACETAMIDE SODIUMOPHTHALMICOINTMENTANDA087748c68ebddc-dcb5-4695-a66b-d03a65a110f6

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1545690861BlephamideANDAA-S Medication Solutions Llc1987-01-01PREDNISOLONE ACETATE, SULFACETAMIDE SODIUMOPHTHALMICOINTMENT000230313ANDA087748e88d861a-77dd-4e4c-a0c8-d9863cd16322
2548681157BlephamideANDAPhysicians Total Care, Inc.2012-03-04PREDNISOLONE ACETATE, SULFACETAMIDE SODIUMOPHTHALMICOINTMENT000230313ANDA08774824636134-1ca9-4a91-acdf-207b8797570f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA087748BLEPHAMIDE S.O.P.ALLERGAN PHARMACEUTICAL1986-12-03ANDA087748_001
2ANDA087771CETAPREDTrueALCON LABORATORIES INC1993-08-06ANDA087771_001
3ANDA088032PREDSULFAIRTruePHARMAFAIR INC1983-04-15ANDA088032_001
4ANDA088791VASOCIDINTrueNOVARTIS PHARMACEUTICALS CORP1984-10-05ANDA088791_001
5NDA010210METIMYDTrueSCHERING CORP SUB SCHERING PLOUGH CORPNDA010210_001, NDA010210_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA087748_001RXPREDNISOLONE ACETATE (0.2%), SULFACETAMIDE SODIUM (10%)OPHTHALMICOINTMENTTrue1986-12-03BLEPHAMIDE S.O.P.
2ANDA087771_001discontinuedPREDNISOLONE ACETATE (0.25%), SULFACETAMIDE SODIUM (10%)OPHTHALMICOINTMENTFalse1993-08-06CETAPRED
3ANDA088032_001discontinuedSULFACETAMIDE SODIUM (10%), PREDNISOLONE ACETATE (0.5%)OPHTHALMICOINTMENTFalse1983-04-15PREDSULFAIR
4ANDA088791_001discontinuedSULFACETAMIDE SODIUM (10%), PREDNISOLONE ACETATE (0.5%)OPHTHALMICOINTMENTFalse1984-10-05VASOCIDIN
5NDA010210_001discontinuedSULFACETAMIDE SODIUM (10%), PREDNISOLONE ACETATE (0.5%)OPHTHALMICSUSPENSION/DROPSFalseMETIMYD
6NDA010210_002discontinuedSULFACETAMIDE SODIUM (10%), PREDNISOLONE ACETATE (0.5%)OPHTHALMICOINTMENTFalse1984-09-09METIMYD

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
124636134-1ca9-4a91-acdf-207b8797570f (view SPL)BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10% / 0.2%prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-03-041548681157
2c68ebddc-dcb5-4695-a66b-d03a65a110f6 (view SPL)BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%sterileprescriptionHuman PrescriptionAllergan, Inc.MANUFACTURE2014-03-074000230313
3e88d861a-77dd-4e4c-a0c8-d9863cd16322 (view SPL)BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10% / 0.2%prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-171545690861

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