FDA.reportPublic FDA data

Application 040069

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATESOLUTION/DROPS;OPHTHALMIC, OTICEQ 0.1% PHOSPHATENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11695-1411Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateButler Animal Health SupplyANDACurrent
24208-720Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateBausch & Lomb IncorporatedANDACurrent
24208-720Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateBausch & Lomb IncorporatedANDACurrent
24208-720Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateBausch & Lomb IncorporatedANDACurrent
42254-088Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateRebel Distributors CorpANDACurrent
57319-065Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphatePhoenix Pharmaceutical, Inc.ANDACurrent
70518-0410Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateREMEDYREPACK INC.ANDACurrent
70518-0410Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateREMEDYREPACK INC.ANDACurrent
70518-0410Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateREMEDYREPACK INC.ANDACurrent
70518-0410Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateREMEDYREPACK INC.ANDACurrent
70518-0410Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateREMEDYREPACK INC.ANDACurrent
70518-0410Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateREMEDYREPACK INC.ANDACurrent