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Details for New Drug Application (NDA): 204760

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NDA 204760 describes MOVANTIK, which is a drug marketed by Astrazeneca Pharms and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug. Additional details are available on the MOVANTIK profile page.

The generic ingredient in MOVANTIK is naloxegol oxalate. Two suppliers are listed for this compound. Additional details are available on the naloxegol oxalate profile page.

Summary for NDA: 204760

Astrazeneca Pharms
naloxegol oxalate

Pharmacology for NDA: 204760

Mechanism of ActionOpioid Antagonists

Suppliers and Packaging for NDA: 204760

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
naloxegol oxalate
TABLET;ORAL 204760 NDA AstraZeneca Pharmaceuticals LP 0310-1969 0310-1969-30 30 TABLET, FILM COATED in 1 BOTTLE (0310-1969-30)
naloxegol oxalate
TABLET;ORAL 204760 NDA AstraZeneca Pharmaceuticals LP 0310-1969 0310-1969-39 10 BLISTER PACK in 1 CARTON (0310-1969-39) > 10 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 12.5MG BASE
Approval Date:Sep 16, 2014TE:RLD:No
Patent:7,662,365Patent Expiration:Oct 18, 2022Product Flag?YSubstance Flag?YDelist Request?
Patent:7,786,133Patent Expiration:Dec 19, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:9,012,469Patent Expiration:Apr 2, 2032Product Flag?YSubstance Flag?YDelist Request?

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