Details for New Drug Application (NDA): 208295
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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.
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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