Details for New Drug Application (NDA): 217770
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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 |
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: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 1.5% | ||||
Approval Date: | Aug 14, 2024 | TE: | AT | RLD: | No |
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