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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040069-001DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040069-001DEXAMETHASONE SODIUM PHOSPHATEEQ 0.1% PHOSPHATESOLUTION/DROPS / OPHTHALMIC, OTICRS1996-07-26a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEBausch & Lomb Incorporated6bdcefbe-51e3-4ca4-afda-5aeca7b6fa732022-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040069
application number: ANDA040069
ndc (product): 24208-720

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

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