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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 208295


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NDA 208295 describes ALVIMOPAN, which is a drug marketed by Hikma, Par Pharm, 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. Five 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 208295
Mechanism of ActionOpioid 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:RXDosage:CAPSULE;ORALStrength12MG
Approval Date:Dec 19, 2019TE:ABRLD:No

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