Details for New Drug Application (NDA): 216843
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NDA 216843 describes ALVIMOPAN, which is a drug marketed by Endo Operations, Hikma, 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 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.
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.
Summary for 216843
| Tradename: | ALVIMOPAN |
| Applicant: | Endo Operations |
| Ingredient: | alvimopan |
| Patents: | 0 |
Pharmacology for NDA: 216843
| Mechanism of Action | Opioid Antagonists |
Suppliers and Packaging for NDA: 216843
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALVIMOPAN | alvimopan | CAPSULE;ORAL | 216843 | ANDA | ENDO USA, Inc. | 0254-3012 | 0254-3012-55 | 6 BLISTER PACK in 1 CARTON (0254-3012-55) / 5 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 12MG | ||||
| Approval Date: | Jan 24, 2023 | TE: | AB | RLD: | No | ||||
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