Details for New Drug Application (NDA): 213551
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NDA 213551 describes CANGRELOR, which is a drug marketed by Gland and is included in one NDA. It is available from one supplier. Additional details are available on the CANGRELOR profile page.
The generic ingredient in CANGRELOR is cangrelor. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cangrelor profile page.
The generic ingredient in CANGRELOR is cangrelor. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cangrelor profile page.
Pharmacology for NDA: 213551
| Mechanism of Action | P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 213551
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CANGRELOR | cangrelor | POWDER;INTRAVENOUS | 213551 | ANDA | Gland Pharma Limited | 68083-412 | 68083-412-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-412-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 50MG/VIAL | ||||
| Approval Date: | Aug 11, 2025 | TE: | AP | RLD: | No | ||||
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