Details for New Drug Application (NDA): 208295
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NDA 208295 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.
Summary for 208295
| Tradename: | ALVIMOPAN |
| Applicant: | Watson Labs Teva |
| Ingredient: | alvimopan |
| Patents: | 0 |
Pharmacology for NDA: 208295
| Mechanism of Action | Opioid Antagonists |
Suppliers and Packaging for NDA: 208295
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALVIMOPAN | alvimopan | CAPSULE;ORAL | 208295 | ANDA | Actavis Pharma, Inc. | 0591-2312 | 0591-2312-15 | 30 BLISTER PACK in 1 CARTON (0591-2312-15) / 1 CAPSULE in 1 BLISTER PACK (0591-2312-45) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 12MG | ||||
| Approval Date: | Dec 19, 2019 | TE: | AB | RLD: | No | ||||
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