Details for New Drug Application (NDA): 206127
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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 206127
Tradename: | EPTIFIBATIDE |
Applicant: | Eugia Pharma |
Ingredient: | eptifibatide |
Patents: | 0 |
Pharmacology for NDA: 206127
Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 206127
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EPTIFIBATIDE | eptifibatide | INJECTABLE;INJECTION | 206127 | ANDA | Eugia US LLC | 55150-218 | 55150-218-99 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-218-99) / 100 mL in 1 VIAL, SINGLE-DOSE |
EPTIFIBATIDE | eptifibatide | INJECTABLE;INJECTION | 206127 | ANDA | Eugia US LLC | 55150-219 | 55150-219-10 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-219-10) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MG/ML | ||||
Approval Date: | Dec 8, 2015 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 75MG/100ML | ||||
Approval Date: | Dec 8, 2015 | TE: | AP | RLD: | No |
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