Details for New Drug Application (NDA): 208554
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The generic ingredient in EPTIFIBATIDE is eptifibatide. There are fifteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the eptifibatide profile page.
Summary for 208554
Tradename: | EPTIFIBATIDE |
Applicant: | Baxter Hlthcare Corp |
Ingredient: | eptifibatide |
Patents: | 0 |
Pharmacology for NDA: 208554
Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 208554
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EPTIFIBATIDE | eptifibatide | INJECTABLE;INJECTION | 208554 | ANDA | Baxter Healthcare Corporation | 0338-9558 | 0338-9558-10 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0338-9558-10) / 100 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 2MG/ML | ||||
Approval Date: | Nov 23, 2018 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 75MG/100ML | ||||
Approval Date: | Nov 23, 2018 | TE: | AP | RLD: | No |
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