Details for New Drug Application (NDA): 214588
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NDA 214588 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.
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 214588
| Tradename: | BEPOTASTINE BESILATE |
| Applicant: | Alembic |
| Ingredient: | bepotastine besilate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 214588
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BEPOTASTINE BESILATE | bepotastine besilate | SOLUTION/DROPS;OPHTHALMIC | 214588 | ANDA | Alembic Pharmaceuticals Limited | 46708-598 | 46708-598-05 | 1 BOTTLE in 1 CARTON (46708-598-05) / 5 mL in 1 BOTTLE |
| BEPOTASTINE BESILATE | bepotastine besilate | SOLUTION/DROPS;OPHTHALMIC | 214588 | ANDA | Alembic Pharmaceuticals Limited | 46708-598 | 46708-598-10 | 1 BOTTLE in 1 CARTON (46708-598-10) / 10 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 1.5% | ||||
| Approval Date: | Apr 5, 2023 | TE: | AT | RLD: | No | ||||
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