prednisolone / Sulfacetamide Ophthalmic Suspension

Brand(s)
Blephamide
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Allergan, Inc. (2014-04-08)
Oldest Current Product
1961-10-01
License(s)
NDA
RxNORM
OPHTHALMIC SUSPENSION\PREDNISOLONE:SULFACETAMIDE
FDAOB
OPHTHALMIC\SUSPENSION\PREDNISOLONE ACETATE: SULFACETAMIDE SODIUM
SPL Active
OPHTHALMIC\SUSPENSION/DROPS\PREDNISOLONE ACETATE: SULFACETAMIDE SODIUM
SPL Moiety
OPHTHALMIC\SUSPENSION/DROPS\PREDNISOLONE: SULFACETAMIDE

product(s) by strength(s)

prednisolone acetate 2 mg/ml / sulfacetamide sodium 100 mg/ml ophthalmic suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1119800022BlephamideNDAAllergan, Inc.1961-10-01PREDNISOLONE ACETATE, SULFACETAMIDE SODIUMOPHTHALMICSUSPENSION/DROPSNDA0128130e5644af-2a3c-493a-bc24-174e5f36235b

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1545690860BlephamideNDAA-S Medication Solutions Llc1961-10-01PREDNISOLONE ACETATE, SULFACETAMIDE SODIUMOPHTHALMICSUSPENSION/DROPS119800022NDA012813f61a1a40-3221-4345-b60d-a850eab7945d
2548680634BlephamideNDAPhysicians Total Care, Inc.1961-10-01PREDNISOLONE ACETATE, SULFACETAMIDE SODIUMOPHTHALMICSUSPENSION/DROPS119800022NDA01281369465827-dd70-483e-84c7-ced49af5d189

application(s)

#idtitledeprecatedapplicantapproved drug
1ANDA087547ISOPTO CETAPREDTrueALCON LABORATORIES INCANDA087547_001
2NDA012813BLEPHAMIDEALLERGAN PHARMACEUTICALNDA012813_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapplication
1ANDA087547_001discontinuedSULFACETAMIDE SODIUM (10%), PREDNISOLONE ACETATE (0.25%)OPHTHALMICSUSPENSIONFalseISOPTO CETAPRED
2NDA012813_002RXPREDNISOLONE ACETATE (0.2%), SULFACETAMIDE SODIUM (10%)OPHTHALMICSUSPENSIONTrueBLEPHAMIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10e5644af-2a3c-493a-bc24-174e5f36235b (view SPL)BLEPHAMIDE (sulfacetamide sodium prednisolone acetate ophthalmic suspension, USP) 10%/0.2%prescriptionHuman PrescriptionAllergan, Inc.MANUFACTURE2014-04-084119800022
269465827-dd70-483e-84c7-ced49af5d189 (view SPL)BLEPHAMIDE (sulfacetamide sodium prednisolone acetate ophthalmic suspension, USP) 10%/0.2%prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2013-11-151548680634
3f61a1a40-3221-4345-b60d-a850eab7945d (view SPL)BLEPHAMIDE (sulfacetamide sodium prednisolone acetate ophthalmic suspension, USP) 10%/0.2%prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-171545690860

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