FDA.reportPublic FDA data

Application 064120

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-315Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateBausch & Lomb IncorporatedANDACurrent
24208-315Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateBausch & Lomb IncorporatedANDACurrent
24208-315Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateBausch & Lomb IncorporatedANDACurrent
24208-315Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateBausch & Lomb IncorporatedANDACurrent
50090-2398Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateA-S Medication SolutionsANDACurrent
50436-4335Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateUnit Dose ServicesANDACurrent
53002-8620Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateRPK Pharmaceuticals, Inc.ANDACurrent
53002-8620Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateRPK Pharmaceuticals, Inc.ANDACurrent
53217-244Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateAidarex Pharmaceuticals LLCANDACurrent
63187-631Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateProficient Rx LPANDACurrent
63187-631Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateProficient Rx LPANDACurrent
63187-631Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateProficient Rx LPANDACurrent
63187-631Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateProficient Rx LPANDACurrent
68071-1651Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1651Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1651Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8152Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfatePreferred Pharmaceuticals Inc.ANDACurrent
70518-0271Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim SulfateREMEDYREPACK INC.ANDACurrent