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 3 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ofloxacinOFLOXACINNorthStar RxLLC7c98c671-aefa-48c3-971a-001f16aa72a82024-08-29Warnings, Adverse reactionsName fallback
brand name: ofloxacin
generic name: OFLOXACIN
ofloxacinOFLOXACIN OTICA-S Medication Solutions71949588-42e2-446c-b7ec-904c09b2f95f2024-08-07Warnings, Adverse reactionsName fallback
brand name: ofloxacin
ofloxacinOFLOXACINNuCare Pharmaceuticals,Inc.ff9776b3-a244-e1ea-e053-6294a90aeb7b2024-08-05Warnings, Adverse reactionsName fallback
brand name: ofloxacin
generic name: OFLOXACIN
ofloxacinOFLOXACIN OTICNuCare Pharmaceuticals,Inc.1e917318-cdc7-cd2c-e063-6294a90a0cc22024-08-02Warnings, Adverse reactionsName fallback
brand name: ofloxacin
OfloxacinOFLOXACINProficient Rx LP5a9de529-6f85-467a-97b0-8ce124c311732024-08-01Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
Ofloxacin OticOFLOXACINA-S Medication Solutions9d4b1225-e20d-4ace-850a-506fd031cac72024-07-18Warnings, Adverse reactionsName fallback
generic name: OFLOXACIN
OfloxacinOFLOXACIN OTICAmneal Pharmaceuticals NY LLCba37e2a0-1bf7-41ca-bddd-35fcb77f87de2024-07-18Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
OfloxacinOFLOXACINNuCare Pharmaceuticals,Inc.af861f20-5ec8-2883-e053-2a95a90a23122024-07-17Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
OfloxacinOFLOXACINNuCare Pharmaceuticals,Inc.ae6b5cb0-aa18-a6d2-e053-2995a90a525d2024-07-17Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
Ofloxacin OticOFLOXACINNuCare Pharmaceuticals,Inc.79ef87c3-1f09-1625-e053-2991aa0a84ae2024-07-17Warnings, Adverse reactionsName fallback
generic name: OFLOXACIN
OFLOXACINOFLOXACINLeading Pharma, LLC7552729e-a41e-4eb1-8b37-b48a861127902024-07-01Warnings, Adverse reactionsName fallback
brand name: OFLOXACIN
generic name: OFLOXACIN
OCUFLOXOFLOXACINAllergan, Inc.7aab4449-3dda-4e2c-8e40-b3244a548bf52024-06-13Warnings, Adverse reactionsName fallback
generic name: OFLOXACIN
ofloxacinOFLOXACIN OTICAsclemed USA, Inc.ff2abdd2-f7ca-49cd-a2d6-cd2bbd980b0c2024-06-12Warnings, Adverse reactionsName fallback
brand name: ofloxacin
ofloxacinOFLOXACINProficient Rx LP0c4e0b81-a344-4678-97d2-b15dc28578822024-05-01Warnings, Adverse reactionsName fallback
brand name: ofloxacin
generic name: OFLOXACIN
OfloxacinOFLOXACINA-S Medication Solutions392d458f-8815-49f4-9c2b-0e721e295b1f2024-04-25Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
OFLOXACINOFLOXACINLeading Pharma, LLCe43bf505-1030-49cd-a144-19b997fb55752024-04-04Warnings, Adverse reactionsName fallback
brand name: OFLOXACIN
generic name: OFLOXACIN
ofloxacinOFLOXACIN OTICProficient Rx LP79074efc-83ed-4473-bb86-9f635928ea922024-03-01Warnings, Adverse reactionsName fallback
brand name: ofloxacin
OfloxacinOFLOXACINNuCare Pharmceuticals,Inc.102c825b-af5c-42e7-e063-6394a90a81a12024-01-30Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
OfloxacinOFLOXACIN OTICA-S Medication Solutionsd89fa470-c98b-433a-829b-abe97eb664192024-01-21Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
ofloxacinOFLOXACINA-S Medication Solutions48dc8354-9a36-427b-ade9-818db6bfb01b2023-11-07Warnings, 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.