Details for New Drug Application (NDA): 204693
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The generic ingredient in EPTIFIBATIDE is eptifibatide. There are fifteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the eptifibatide profile page.
Summary for 204693
Tradename: | EPTIFIBATIDE |
Applicant: | Sagent Pharms Inc |
Ingredient: | eptifibatide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204693
Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 204693
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EPTIFIBATIDE | eptifibatide | INJECTABLE;INJECTION | 204693 | ANDA | Sagent Pharmaceuticals | 25021-408 | 25021-408-51 | 1 VIAL in 1 CARTON (25021-408-51) / 100 mL in 1 VIAL |
EPTIFIBATIDE | eptifibatide | INJECTABLE;INJECTION | 204693 | ANDA | Sagent Pharmaceuticals | 25021-409 | 25021-409-10 | 1 VIAL in 1 CARTON (25021-409-10) / 10 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MG/ML | ||||
Approval Date: | Mar 7, 2018 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 75MG/100ML | ||||
Approval Date: | Mar 7, 2018 | TE: | AP | RLD: | No |
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