Details for New Drug Application (NDA): 217753
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The generic ingredient in ALVIMOPAN is alvimopan. There are four drug master file entries 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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