FDA.reportPublic FDA data

Application 050567

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POLYTRIMPOLYMYXIN B SULFATE; TRIMETHOPRIM SULFATESOLUTION/DROPS;OPHTHALMIC10,000 UNITS/ML;EQ 1MG BASE/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-7824Polytrimpolymyxin b sulfate and trimethoprim sulfateAllergan, Inc.NDACurrent
0023-7824Polytrimpolymyxin b sulfate and trimethoprim sulfateAllergan, Inc.NDACurrent
0023-7824Polytrimpolymyxin b sulfate and trimethoprim sulfateAllergan, Inc.NDACurrent
50090-1540Polytrimpolymyxin b sulfate and trimethoprim sulfateA-S Medication SolutionsNDACurrent
50090-2064POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATEpolymyxin B sulfate, trimethoprim sulfateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
52959-609POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATEpolymyxin B sulfate, trimethoprim sulfateH.J. Harkins Company, Inc.NDA AUTHORIZED GENERICCurrent
55700-105POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATEpolymyxin B sulfate, trimethoprim sulfateQuality Care Products LLCNDA AUTHORIZED GENERICCurrent
55700-105POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATEpolymyxin B sulfate, trimethoprim sulfateLake Erie Medical DBA Quality Care Products LLCNDA AUTHORIZED GENERICCurrent
55700-105POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATEpolymyxin B sulfate, trimethoprim sulfateQuality Care Products LLCNDA AUTHORIZED GENERICCurrent
55700-105POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATEpolymyxin B sulfate, trimethoprim sulfateQuality Care Products LLCNDA AUTHORIZED GENERICCurrent
60758-908POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATEpolymyxin B sulfate, trimethoprim sulfatePacific Pharma, Inc.NDA AUTHORIZED GENERICCurrent
60758-908POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATEpolymyxin B sulfate, trimethoprim sulfatePacific Pharma, Inc.NDA AUTHORIZED GENERICCurrent
61919-233POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEDIRECT RXNDA AUTHORIZED GENERICCurrent
61919-233POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEDIRECT RXNDA AUTHORIZED GENERICCurrent
61919-233POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEDIRECT RXNDA AUTHORIZED GENERICCurrent
70518-3206POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATEpolymyxin B sulfate, trimethoprim sulfateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-3206POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATEpolymyxin B sulfate, trimethoprim sulfateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83287SUPPL 2025-09-05
83041SUPPL 2025-08-05