FDA.reportPublic FDA data

Application 064211

Type
ANDA
Sponsor
SANDOZ INC

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
21695-335Polymyxin B Sulfate and Trimethoprimpolymyxin B sulfate and trimethoprimRebel Distributors CorpANDACurrent
50090-2925Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimA-S Medication SolutionsANDACurrent
50090-2925Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimA-S Medication SolutionsANDACurrent
53002-8621Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimRPK Pharmaceuticals, Inc.ANDACurrent
53002-8621Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimRPK Pharmaceuticals, Inc.ANDACurrent
53217-305Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimAidarex Pharmaceuticals LLCANDACurrent
61314-628Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimSandoz IncANDACurrent
61314-628Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimSandoz IncANDACurrent
61314-628Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimSandoz IncANDACurrent
61919-115POLYMYXIN B SULFATE AND TRIMETHOPRIMPOLYMYXIN B SULFATE AND TRIMETHOPRIMDIRECT RXANDACurrent
61919-215POLYMYXIN B SULFATE AND TRIMETHOPRIMPOLYMYXIN B SULFATE AND TRIMETHOPRIMDIRECT RXANDACurrent
63187-834Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimProficient Rx LPANDACurrent
63187-834Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimProficient Rx LPANDACurrent
63187-834Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimProficient Rx LPANDACurrent
63187-834Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimProficient Rx LPANDACurrent
68071-4103Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4103Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6927Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimPreferred Pharmacetucials Inc.ANDACurrent
68788-6927Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimPreferred Pharmacetucials Inc.ANDACurrent
68788-6927Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimPreferred Pharmacetucials Inc.ANDACurrent
68788-6927Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimPreferred Pharmacetucials Inc.ANDACurrent
68788-6927Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimPreferred Pharmacetucials Inc.ANDACurrent
70518-1735Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimREMEDYREPACK INC.ANDACurrent
70518-1735Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimREMEDYREPACK INC.ANDACurrent
70518-1735Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimREMEDYREPACK INC.ANDACurrent
70518-1735Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimREMEDYREPACK INC.ANDACurrent
70518-1735Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimREMEDYREPACK INC.ANDACurrent
70518-1735Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and TrimethoprimREMEDYREPACK INC.ANDACurrent