FDA.reportPublic FDA data

Application 206080

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BEPOTASTINE BESILATEBEPOTASTINE BESILATESOLUTION;OPHTHALMIC1.5%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 1 of 1 ยท 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bepotastine BesilateBEPOTASTINE BESILATESomerset Therapeutics, LLCcd6a061d-8ad7-4ad1-b039-1e3aa3435d322024-10-10Warnings, Adverse reactionsName fallback
brand name: Bepotastine Besilate
generic name: BEPOTASTINE BESILATE
Bepotastine BesilateBEPOTASTINE BESILATEBausch & Lomb Americas Inc.70430ab5-cd0a-451e-acab-347a2f9818982024-08-20Warnings, Adverse reactionsName fallback
brand name: Bepotastine Besilate
generic name: BEPOTASTINE BESILATE
BepreveBEPOTASTINE BESILATEBausch & Lomb Incorporated68bbf6a0-c4b5-47c1-8a1c-08220fbdbce62022-08-31Warnings, Adverse reactionsName fallback
generic name: BEPOTASTINE BESILATE
Bepotastine BesilateBEPOTASTINE BESILATEBausch & Lomb Incorporated995f4fe0-d861-4137-8090-a8ffc71c46f42020-12-31Warnings, Adverse reactionsName fallback
brand name: Bepotastine Besilate
generic name: BEPOTASTINE BESILATE
Bepotastine BesilateBEPOTASTINE BESILATEMylan Pharmaceuticals Inc.75178670-aa57-45f9-94d5-efcf8305e6832018-03-20Warnings, Adverse reactionsName fallback
brand name: Bepotastine Besilate
generic name: BEPOTASTINE BESILATE

Reported adverse events (FAERS/openFDA)#

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