Details for New Drug Application (NDA): 217753
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NDA 217753 describes ALVIMOPAN, which is a drug marketed by Hikma, Ph Health, and Watson Labs Teva, and is included in three NDAs. It is available from four suppliers. Additional details are available on the ALVIMOPAN profile page.
The generic ingredient in ALVIMOPAN is alvimopan. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the alvimopan profile page.
The generic ingredient in ALVIMOPAN is alvimopan. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the alvimopan profile page.
Pharmacology for NDA: 217753
| Mechanism of Action | Opioid Antagonists |
Suppliers and Packaging for NDA: 217753
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALVIMOPAN | alvimopan | CAPSULE;ORAL | 217753 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0668 | 0054-0668-82 | 6 BLISTER PACK in 1 CARTON (0054-0668-82) / 5 CAPSULE in 1 BLISTER PACK |
| ALVIMOPAN | alvimopan | CAPSULE;ORAL | 217753 | ANDA | Golden State Medical Supply, Inc. | 51407-870 | 51407-870-33 | 5 BLISTER PACK in 1 CARTON (51407-870-33) / 6 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 12MG | ||||
| Approval Date: | Aug 31, 2023 | TE: | AB | RLD: | No | ||||
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