FDA.reportPublic FDA data

Application 218557

Type
ANDA
Sponsor
MICRO LABS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A218557-001OFLOXACINOFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2026-04-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A218557-001AT

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A218557-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2026-04-0884e616aacf4f…
2026-08-18 06:07:402026-07A218557-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2026-04-08caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218557-001OFLOXACIN0.3%SOLUTION/DROPS / OPHTHALMICAT2026-04-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218557-001AT184e616aacf4f…
2026-08-18 06:07:402026-07A218557-001AT1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218557-001AT1a50c72e98297…

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 4 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OfloxacinOFLOXACINARMAS PHARMACEUTICALS INC.07ac850b-a983-fc21-e063-6394a90a21b22023-10-23Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
OfloxacinOFLOXACINA-S Medication Solutionsff88214e-19b5-428d-a10d-91c3edc89a662023-08-14Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
OfloxacinOFLOXACINBausch & Lomb Incorporatedc5484f1a-2321-453f-9469-dfcf709e2e2e2023-05-31Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
Ofloxacin ophthalmicOFLOXACINAltaire Pharmaceuticals Inc.fe564e33-8f5d-4b57-87a9-7afae02eaf972022-10-28Warnings, Adverse reactionsName fallback
generic name: OFLOXACIN
Ofloxacin OticOFLOXACINProficient Rx LP14e6e355-3a87-43dc-80a2-070b9df93bf12022-09-01Warnings, Adverse reactionsName fallback
generic name: OFLOXACIN
OfloxacinOFLOXACINProficient Rx LP2d2807a8-19d5-4922-8270-a8885d61e8512022-08-01Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
OfloxacinOFLOXACINProficient Rx LPbfe09726-9acb-4032-be91-ef2614662ae22022-07-01Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
OfloxacinOFLOXACINProficient Rx LPc8020ad4-ac74-4ceb-863e-94da605cf23f2022-04-01Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
OfloxacinOFLOXACINProficient Rx LPa2089612-de4b-4d78-b311-fa2524bd37f62020-02-01Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN

Reported adverse events (FAERS/openFDA)#

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