Details for New Drug Application (NDA): 209864
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NDA 209864 describes EPTIFIBATIDE, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Baxter Hlthcare Corp, Eugia Pharma, Hong Kong, Hybio, Mylan Labs Ltd, Rising, Sagent Pharms Inc, Shuangcheng, Slate Run Pharma, Teva Pharms Usa, and USV, and is included in fifteen NDAs. It is available from nine suppliers. Additional details are available on the EPTIFIBATIDE profile page.
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.
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 209864
| Tradename: | EPTIFIBATIDE |
| Applicant: | Slate Run Pharma |
| Ingredient: | eptifibatide |
| Patents: | 0 |
Pharmacology for NDA: 209864
| Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 209864
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPTIFIBATIDE | eptifibatide | INJECTABLE;INJECTION | 209864 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-026 | 70436-026-80 | 10 mL in 1 VIAL (70436-026-80) |
| EPTIFIBATIDE | eptifibatide | INJECTABLE;INJECTION | 209864 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-027 | 70436-027-80 | 100 mL in 1 VIAL (70436-027-80) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MG/ML | ||||
| Approval Date: | Jan 25, 2019 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 75MG/100ML | ||||
| Approval Date: | Jan 25, 2019 | TE: | AP | RLD: | No | ||||
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