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 42.

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
2026-08-18 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
2026-08-18 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 1 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ofloxacinOFLOXACIN OTICREMEDYREPACK INC.50bca624-4dc0-4d1b-a693-2eb602eaf2f22026-08-14Warnings, Adverse reactionsName fallback
brand name: ofloxacin
OfloxacinOFLOXACINREMEDYREPACK INC.38d0bbce-58ca-4fc1-a887-87b61fef9a872026-08-14Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
ofloxacinOFLOXACIN OTICNorthStar RxLLCb95114f6-6753-4217-b621-44fa34afc2982026-08-13Warnings, Adverse reactionsName fallback
brand name: ofloxacin
ofloxacinOFLOXACIN OTICLifestar Pharma LLC0621700e-6315-47ff-a8ed-cccf7d6fc56a2026-08-13Warnings, Adverse reactionsName fallback
brand name: ofloxacin
OfloxacinOFLOXACINPreferred Pharmaceuticals, Inc.0c01de7a-a885-4bf0-8df0-7c62170b78502026-08-06Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
ofloxacinOFLOXACINPreferred Pharmaceuticals Inc.306ed758-3c43-4f42-bd44-562ec65891dc2026-08-06Warnings, Adverse reactionsName fallback
brand name: ofloxacin
generic name: OFLOXACIN
ofloxacinOFLOXACIN OTICSportpharm LLC3f5972db-4eaf-4237-944d-8f63eff7b9b12026-06-26Warnings, Adverse reactionsName fallback
brand name: ofloxacin
OfloxacinOFLOXACINSt. Mary's Medical Park Pharmacy2d55b26d-9d12-ca29-e063-6294a90ab2372026-06-25Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
OFLOXACINOFLOXACINModavar Pharmaceuticals LLC93ed9f70-b44f-496b-bdfc-c1bd5f1c260b2026-06-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OFLOXACIN
generic name: OFLOXACIN
OfloxacinOFLOXACINST. MARY'S MEDICAL PARK PHARMACY27c247e5-ef93-e9a5-e063-6394a90a2e1e2026-06-03Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
ofloxacinOFLOXACINREMEDYREPACK INC.d97651cc-d9ea-4be4-8ea1-3d0278582dd52026-04-15Warnings, Adverse reactionsName fallback
brand name: ofloxacin
generic name: OFLOXACIN
OFLOXACIN OTICOFLOXACINDIRECT RXa7952956-b64a-0f99-e053-2995a90a0f912026-03-17Warnings, Adverse reactionsName fallback
generic name: OFLOXACIN
OfloxacinOFLOXACINPreferred Pharmaceuticals Inc.5f4213e4-de32-4c03-8800-e254b98538ea2026-03-17Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
OfloxacinOFLOXACINA-S Medication Solutions537c6351-c7f1-47c9-95de-011bac8507682026-01-23Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
OfloxacinOFLOXACINPreferred Pharmaceuticals Inc.f7916bb3-7593-45f8-b9de-98e0f2d572272026-01-19Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
OfloxacinOFLOXACINRising Pharma Holdings, Inc.2e912ed6-51e8-40c3-bf10-2af092c63be82026-01-02Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
OfloxacinOFLOXACINRedpharm Drug2fbd51a5-462c-4741-e063-6394a90a0d872025-12-30Warnings, Adverse reactionsName fallback
brand name: Ofloxacin
generic name: OFLOXACIN
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