FDA.reportPublic FDA data

Application 062501

Type
ANDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GENTACIDINGENTAMICIN SULFATEOINTMENT;OPHTHALMICEQ 0.3% BASENoNo

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
A062501-001GENTACIDINGENTAMICIN SULFATEEQ 0.3% BASEOINTMENT / OPHTHALMIC1984-07-26

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A062501-001GENTACIDINEQ 0.3% BASEOINTMENT / OPHTHALMIC1984-07-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062501-001GENTACIDINEQ 0.3% BASEOINTMENT / OPHTHALMIC1984-07-26cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A062501-001GENTACIDINEQ 0.3% BASEOINTMENT / OPHTHALMIC1984-07-26a50c72e98297…

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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentamicin SulfateGENTAMICIN SULFATEHospira, Inc.977180b3-a222-4282-d485-4a32176743052026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATECardinal Health 107, LLC5113bfad-42ca-4bb8-9343-0b08c6cd03f02026-05-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATEPreferred Pharmaceuticals Inc.5ac8ea7a-ee89-49f5-8d30-6dbb56503d942026-05-05Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
GentamicinGENTAMICIN SULFATEHenry Schein, Inc84f6eb1c-a287-489a-8c3e-aa5954cf19922025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATEHenry Schein, Inc.913a36c3-50d6-429a-a8dd-a03126d2ca082025-10-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATEMedical Purchasing Solutions, LLC3532bb39-a1a6-9d67-e063-6294a90abc0c2025-05-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATEProficient Rx LP5193ed8d-44c9-46fe-924d-93aaea922cfd2025-05-01Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.0bef2a01-69d0-cf50-e063-6294a90a4c522025-02-03Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
GentamicinGENTAMICIN SULFATEFresenius Kabi USA, LLC84f5c763-1cd3-4d85-9afb-934db8666fbf2024-10-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals, Inc.4add8f7b-48f0-6b6a-e054-00144ff88e882024-08-14Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATEBausch & Lomb Incorporated41d01350-5c4b-42fc-be5f-986ceec02bd32024-07-22Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.82595309-304e-a221-e053-2991aa0ac0a92024-06-14Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
GENTAMICIN SULFATEGENTAMICIN SULFATENuCare Pharmaceuticals,Inc.85424b40-5c2d-421d-e053-2991aa0a77712024-06-14Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
GENTAMICIN SULFATEGENTAMICIN SULFATEHF Acquisition Co LLC, DBA HealthFirste9fbe619-2afe-f1d7-e053-2a95a90aab292024-01-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATEPadagis Israel Pharmaceuticals Ltda9486ae1-350b-41c5-ae0c-a4d692bb2dfd2024-01-15Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
gentamicin sulfateGENTAMICIN SULFATEDIRECT RX51a411a0-2671-4c1c-bf25-e29b32efed0c2024-01-10Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATESandoz Inca213fb9c-08ea-4f30-a6c9-93c7a9ba52802024-01-02Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATECosette Pharmaceuticals, Inc.16474069-510b-0754-9d78-9bc0354f65492023-11-23Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
Gentamicin SulfateGENTAMICIN SULFATECosette Pharmaceuticals, Inc.9e550dc9-509e-da05-8a97-ecbd0f5dd6332023-11-22Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE
GentamicinGENTAMICIN SULFATEMedical Purchasing Solutions, LLC09cf88af-59da-f147-e063-6294a90aac992023-11-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: GENTAMICIN SULFATE

Reported adverse events (FAERS/openFDA)#

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