FDA.reportPublic FDA data

Application 064134

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOBRAMYCIN AND DEXAMETHASONEDEXAMETHASONE; TOBRAMYCINSUSPENSION/DROPS;OPHTHALMIC0.1%;0.3%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-295Tobramycin and DexamethasoneTobramycin and DexamethasoneBausch & Lomb IncorporatedANDACurrent
24208-295Tobramycin and DexamethasoneTobramycin and DexamethasoneBausch & Lomb IncorporatedANDACurrent
24208-295Tobramycin and DexamethasoneTobramycin and DexamethasoneBausch & Lomb IncorporatedANDACurrent
24208-295Tobramycin and DexamethasoneTobramycin and DexamethasoneBausch & Lomb IncorporatedANDACurrent
24208-295Tobramycin and DexamethasoneTobramycin and DexamethasoneBausch & Lomb IncorporatedANDACurrent
24208-295Tobramycin and DexamethasoneTobramycin and DexamethasoneBausch & Lomb IncorporatedANDACurrent
50090-1893Tobramycin and DexamethasoneTobramycin and DexamethasoneA-S Medication SolutionsANDACurrent
50090-1893Tobramycin and DexamethasoneTobramycin and DexamethasoneA-S Medication SolutionsANDACurrent
50090-1914Tobramycin and DexamethasoneTobramycin and DexamethasoneA-S Medication SolutionsANDACurrent
50090-1914Tobramycin and DexamethasoneTobramycin and DexamethasoneA-S Medication SolutionsANDACurrent
55700-915Tobramycin and DexamethasoneTobramycin and DexamethasoneQuality Care Products, LLCANDACurrent
55700-915Tobramycin and DexamethasoneTobramycin and DexamethasoneQuality Care Products, LLCANDACurrent
55700-915Tobramycin and DexamethasoneTobramycin and DexamethasoneQuality Care Products, LLCANDACurrent
68071-1655Tobramycin and DexamethasoneTobramycin and DexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1821Tobramycin and DexamethasoneTobramycin and DexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1821Tobramycin and DexamethasoneTobramycin and DexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2418Tobramycin and DexamethasoneTobramycin and DexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4203Tobramycin and DexamethasoneTobramycin and DexamethasoneNuCare Pharmaceuticals,InANDACurrent
68071-4203Tobramycin and DexamethasoneTobramycin and DexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4203Tobramycin and DexamethasoneTobramycin and DexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9342Tobramycin and DexamethasoneTobramycin and DexamethasonePreferred PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39411ORIG2004-06-28
42782ORIG2002-01-17
8350ORIG1999-10-27