Details for New Drug Application (NDA): 218047
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NDA 218047 describes ERIBULIN MESYLATE, which is a drug marketed by Baxter Hlthcare Corp, Gland Pharma Ltd, Jiangxi Qingfeng, and Long Grove Pharms, and is included in four NDAs. It is available from four suppliers. Additional details are available on the ERIBULIN MESYLATE profile page.
The generic ingredient in ERIBULIN MESYLATE is eribulin mesylate. Six suppliers are listed for this compound. Additional details are available on the eribulin mesylate profile page.
The generic ingredient in ERIBULIN MESYLATE is eribulin mesylate. Six suppliers are listed for this compound. Additional details are available on the eribulin mesylate profile page.
Summary for 218047
| Tradename: | ERIBULIN MESYLATE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | eribulin mesylate |
| Patents: | 0 |
Pharmacology for NDA: 218047
| Physiological Effect | Microtubule Inhibition |
Suppliers and Packaging for NDA: 218047
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERIBULIN MESYLATE | eribulin mesylate | SOLUTION;INTRAVENOUS | 218047 | ANDA | Apotex Corp. | 60505-6289 | 60505-6289-0 | 1 VIAL, SINGLE-DOSE in 1 CARTON (60505-6289-0) / 2 mL in 1 VIAL, SINGLE-DOSE |
| ERIBULIN MESYLATE | eribulin mesylate | SOLUTION;INTRAVENOUS | 218047 | ANDA | Gland Pharma Limited | 68083-592 | 68083-592-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-592-01) / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1MG/2ML (0.5MG/ML) | ||||
| Approval Date: | Apr 5, 2024 | TE: | AP | RLD: | No | ||||
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