Details for New Drug Application (NDA): 218743
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The generic ingredient in ERIBULIN MESYLATE is eribulin mesylate. Fourteen suppliers are listed for this compound. Additional details are available on the eribulin mesylate profile page.
Summary for 218743
| Tradename: | ERIBULIN MESYLATE |
| Applicant: | Chia Tai Tianqing |
| Ingredient: | eribulin mesylate |
| Patents: | 0 |
Pharmacology for NDA: 218743
| Physiological Effect | Microtubule Inhibition |
Suppliers and Packaging for NDA: 218743
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERIBULIN MESYLATE | eribulin mesylate | SOLUTION;INTRAVENOUS | 218743 | ANDA | Sun Pharmaceutical Industries Limited | 70095-080 | 70095-080-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70095-080-01) / 2 mL in 1 VIAL, SINGLE-DOSE |
| ERIBULIN MESYLATE | eribulin mesylate | SOLUTION;INTRAVENOUS | 218743 | ANDA | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 71731-4171 | 71731-4171-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71731-4171-1) / 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: | Mar 4, 2025 | TE: | AP | RLD: | No | ||||
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