Details for New Drug Application (NDA): 205557
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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 205557
Tradename: | EPTIFIBATIDE |
Applicant: | Accord Hlthcare |
Ingredient: | eptifibatide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205557
Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 205557
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EPTIFIBATIDE | eptifibatide | INJECTABLE;INJECTION | 205557 | ANDA | Accord Healthcare Inc. | 16729-259 | 16729-259-38 | 1 VIAL, SINGLE-USE in 1 CARTON (16729-259-38) / 100 mL in 1 VIAL, SINGLE-USE |
EPTIFIBATIDE | eptifibatide | INJECTABLE;INJECTION | 205557 | ANDA | Accord Healthcare Inc. | 16729-260 | 16729-260-03 | 1 VIAL, SINGLE-USE in 1 CARTON (16729-260-03) / 10 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MG/ML | ||||
Approval Date: | Nov 6, 2017 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 75MG/100ML | ||||
Approval Date: | Nov 6, 2017 | TE: | AP | RLD: | No |
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