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 2 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OFLOXACINOFLOXACINRedpharm Drug37456656-77c8-d74c-e063-6294a90ab7292025-12-13Warnings, Adverse reactionsName fallback
brand name: OFLOXACIN
generic name: OFLOXACIN
OfloxacinOFLOXACIN OPHTHALMIC SOLUTION USP, 0.3%SOLA Pharmaceuticals, LLC4ca27244-ed70-4868-b2d8-8f97c3a521482025-12-08Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
OfloxacinOFLOXACINRedpharm Drug3dd035d0-c3ec-3fc2-e063-6294a90a4aac2025-12-02Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
ofloxacinOFLOXACINNuCare Pharmaceuticals, Inc.4484283c-7839-e75d-e063-6394a90a86392025-11-26Warnings, Adverse reactionsName fallback
brand name: ofloxacin
generic name: OFLOXACIN
ofloxacinOFLOXACINA-S Medication Solutions8fd1eba2-2ed2-40a8-ae10-957b07434fe52025-11-12Warnings, Adverse reactionsName fallback
brand name: ofloxacin
generic name: OFLOXACIN
Ofloxacin OticOFLOXACINBryant Ranch Prepack7ba2d774-27d8-4ee0-9ef3-cc4900dcc5fa2025-10-30Warnings, Adverse reactionsName fallback
generic name: OFLOXACIN
OfloxacinOFLOXACINA-S Medication Solutionsab5b0e34-ac5c-4c0c-b104-934b319ae0112025-08-15Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
OfloxacinOFLOXACINBausch & Lomb Incorporatedad40954d-0b1d-47c5-8bd5-8a1efd9a71532025-06-12Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
OfloxacinOFLOXACIN OPHTHALMIC SOLUTION USP, 0.3%Caplin Steriles Limited53f7ec2e-5b4c-4f8c-b8ba-7f8844e0c01b2025-02-05Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
Ofloxacin OticOFLOXACINNuCare Pharmaceuticals,Inc.76f461da-0e15-aa6d-e053-2a91aa0a98082024-12-26Warnings, Adverse reactionsName fallback
generic name: OFLOXACIN
OfloxacinOFLOXACINNuCare Pharmaceuticals, Inc.51f3d155-36df-4c40-e054-00144ff8d46c2024-12-24Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
ofloxacinOFLOXACINLifestar Pharma LLC871d63f4-41c1-4b30-903c-11fbf0d4c1f82024-12-23Warnings, Adverse reactionsName fallback
brand name: ofloxacin
generic name: OFLOXACIN
OfloxacinOFLOXACIN OTICCaplin Steriles Limited2bb61a24-87a6-4e74-a319-fc5e7c483bbb2024-12-16Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
ofloxacinOFLOXACINMajor Pharmaceuticals2d7a1f80-1c59-49e6-aff7-aedacade2dd62024-11-12Warnings, Adverse reactionsName fallback
brand name: ofloxacin
generic name: OFLOXACIN
OfloxacinOFLOXACINSomerset Therapeutics, LLC72ad7b86-1d5b-48c9-bb40-319d6c186f1d2024-10-31Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
OfloxacinOFLOXACINA-S Medication Solutions1838671d-e312-442a-b0bc-6702d6a8965c2024-10-14Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
OfloxacinOFLOXACINSomerset Therapeutics, LLC4b2b893d-c19b-4c4a-85de-ff901325080b2024-10-11Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
Ofloxacin OticOFLOXACINBryant Ranch Prepack4f4048b2-3ae8-441a-b1e3-7311fac00f942024-09-20Warnings, Adverse reactionsName fallback
generic name: OFLOXACIN
Ofloxacin OticOFLOXACINBryant Ranch Prepack567fa672-5fd0-4a1d-bc12-054a9ac161172024-09-19Warnings, Adverse reactionsName fallback
generic name: OFLOXACIN
OFLOXACINOFLOXACINCadila Pharmaceuticals Limitedc677b35c-0432-4ee5-af57-1f95449c48b62024-09-12Boxed warning, Warnings, 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.