FDA.reportPublic FDA data

Application 204912

Type
ANDA
Sponsor
AKORN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIMOLOL MALEATETIMOLOL MALEATESOLUTION;OPHTHALMIC0.5%NoNo

Source provenance: Browse the complete Orange Book source catalog.

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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Timolol MaleateTIMOLOL MALEATERising Pharma Holdings, Inc.0bc40b2c-65eb-4095-87e6-4752d5b19a3a2024-06-11Warnings, Adverse reactionsName fallback
brand name: Timolol Maleate
generic name: TIMOLOL MALEATE
TIMOLOL MALEATETIMOLOL MALEATEA-S Medication Solutions1ffd9ed1-8ab4-4036-bbc6-dcf58e6592482024-06-03Warnings, Adverse reactionsName fallback
brand name: TIMOLOL MALEATE
generic name: TIMOLOL MALEATE
Timolol GFSTIMOLOL MALEATESandoz Inc72b0d0ec-832a-4c25-b845-2537ab5063542024-05-28Warnings, Adverse reactionsName fallback
generic name: TIMOLOL MALEATE
TIMOLOL MALEATETIMOLOL MALEATEAurobindo Pharma Limitede6c74f66-ee84-4bcc-b1da-b8e6ff240dd22024-05-16Warnings, Adverse reactionsName fallback
brand name: TIMOLOL MALEATE
generic name: TIMOLOL MALEATE
TIMOLOL MALEATETIMOLOL MALEATEPacific Pharma, Inc.e16c33fd-aa86-49ad-a767-c79ade4a62c72024-03-14Warnings, Adverse reactionsName fallback
brand name: TIMOLOL MALEATE
generic name: TIMOLOL MALEATE
timolol maleateTIMOLOL MALEATEFirst Nation Group, LLC140e1bfc-b75e-40d1-856c-242be4d9c8cc2024-03-07Warnings, Adverse reactionsName fallback
brand name: timolol maleate
generic name: TIMOLOL MALEATE
Timolol MaleateTIMOLOL MALEATEIngenus Pharmaceuticals, LLC4c4318b3-9865-4172-a7bd-9e68913eca1e2023-10-25Warnings, Adverse reactionsName fallback
brand name: Timolol Maleate
generic name: TIMOLOL MALEATE
timolol maleateTIMOLOL MALEATELifestar Pharma LLC545b7bee-8d5d-4206-b973-8de3c14d6dfe2023-07-03Warnings, Adverse reactionsName fallback
brand name: timolol maleate
generic name: TIMOLOL MALEATE
TimopticTIMOLOL MALEATEBausch & Lomb Incorporated45ac65b3-19f7-4f33-aebf-cadd3daa4bf12022-04-30Warnings, Adverse reactionsName fallback
generic name: TIMOLOL MALEATE
Timoptic-XETIMOLOL MALEATEBausch & Lomb Incorporateda4d03de7-06b7-4cfc-9d1b-616969df209c2022-03-31Warnings, Adverse reactionsName fallback
generic name: TIMOLOL MALEATE
Timoptic in OcudoseTIMOLOL MALEATEBausch & Lomb Incorporatedd130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf2022-01-31Warnings, Adverse reactionsName fallback
generic name: TIMOLOL MALEATE
Timolol MaleateTIMOLOL MALEATEMylan Pharmaceuticals Inc.57c62928-63d8-4505-9b9e-c085a3a12c952020-07-06Warnings, Adverse reactionsName fallback
brand name: Timolol Maleate
generic name: TIMOLOL MALEATE

Reported adverse events (FAERS/openFDA)#

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