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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 217770


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NDA 217770 describes BEPOTASTINE BESILATE, which is a drug marketed by Alembic, Apotex, Mylan, and Somerset Theraps Llc, and is included in four NDAs. It is available from four suppliers. Additional details are available on the BEPOTASTINE BESILATE profile page.

The generic ingredient in BEPOTASTINE BESILATE is bepotastine besilate. There are seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bepotastine besilate profile page.
Summary for 217770
Tradename:BEPOTASTINE BESILATE
Applicant:Somerset Theraps Llc
Ingredient:bepotastine besilate
Patents:0
Pharmacology for NDA: 217770
Suppliers and Packaging for NDA: 217770
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BEPOTASTINE BESILATE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 217770 ANDA Somerset Therapeutics, LLC 70069-711 70069-711-01 1 BOTTLE in 1 CARTON (70069-711-01) / 5 mL in 1 BOTTLE
BEPOTASTINE BESILATE bepotastine besilate SOLUTION/DROPS;OPHTHALMIC 217770 ANDA Somerset Therapeutics, LLC 70069-712 70069-712-01 1 BOTTLE in 1 CARTON (70069-712-01) / 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength1.5%
Approval Date:Aug 14, 2024TE:ATRLD:No

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