FDA.reportPublic FDA data

Application 064052

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOBRAMYCINTOBRAMYCINSOLUTION/DROPS;OPHTHALMIC0.3%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13985-743TobramycinTobramycinMWIANDACurrent
24208-290TobramycinTobramycinBausch & Lomb IncorporatedANDACurrent
24208-290TobramycinTobramycinBausch & Lomb IncorporatedANDACurrent
24208-290TobramycinTobramycinBausch & Lomb IncorporatedANDACurrent
24208-290TobramycinTobramycinBausch & Lomb IncorporatedANDACurrent
24208-290TobramycinTobramycinBausch & Lomb IncorporatedANDACurrent
24208-290TobramycinTobramycinBausch & Lomb IncorporatedANDACurrent
24208-290TobramycinTobramycinBausch & Lomb IncorporatedANDACurrent
24208-290TobramycinTobramycinBausch & Lomb IncorporatedANDACurrent
42254-187TobramycinTobramycinRebel Distributors CorpANDACurrent
50090-2127TobramycinTobramycinA-S Medication SolutionsANDACurrent
50090-2127TobramycinTobramycinA-S Medication SolutionsANDACurrent
52959-108TobramycinTobramycinH.J. Harkins Company, Inc.ANDACurrent
53002-9230TobramycinTobramycinRPK Pharmaceuticals, Inc.ANDACurrent
53002-9230TobramycinTobramycinRPK Pharmaceuticals, Inc.ANDACurrent
55700-380TobramycinTobramycinLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-224TOBRAMYCINTOBRAMYCINDirect RxANDACurrent
63187-024TobramycinTobramycinProficient Rx LPANDACurrent
63187-024TobramycinTobramycinProficient Rx LPANDACurrent
63187-024TobramycinTobramycinProficient Rx LPANDACurrent
66267-936TobramycinTobramycinNuCare Pharmaceuticals,Inc.ANDACurrent
66267-936TobramycinTobramycinNuCare Pharmaceuticals,Inc.ANDACurrent
66267-936TobramycinTobramycinNuCare Pharmaceuticals,Inc.ANDACurrent
66267-936TobramycinTobramycinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8248TobramycinTobramycinPreferred Pharmaceuticals Inc.ANDACurrent
68788-9870TobramycinTobramycinPreferred PharmaceuticalsANDACurrent
70518-0319TobramycinTobramycinREMEDYREPACK INC.ANDACurrent
70518-0319TobramycinTobramycinREMEDYREPACK INC.ANDACurrent