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Generated: November 17, 2018

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Details for New Drug Application (NDA): 022522

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NDA 022522 describes DALIRESP, 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 and one Paragraph IV challenge. Additional details are available on the DALIRESP profile page.

The generic ingredient in DALIRESP is roflumilast. There are ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the roflumilast profile page.
Summary for 022522
Tradename:DALIRESP
Applicant:Astrazeneca Pharms
Ingredient:roflumilast
Patents:6
Pharmacology for NDA: 022522
Suppliers and Packaging for NDA: 022522
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DALIRESP roflumilast TABLET;ORAL 022522 NDA AstraZeneca Pharmaceuticals LP 0310-0088 0310-0088-28 1 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-28) > 28 TABLET in 1 BLISTER PACK
DALIRESP roflumilast TABLET;ORAL 022522 NDA AstraZeneca Pharmaceuticals LP 0310-0088 0310-0088-39 10 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-39) > 2 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MCG
Approval Date:Feb 28, 2011TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Aug 31, 2020
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING TO INCLUDE RESULTS OF A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY IN PATIENTS WITH SEVERE COPD ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS
Regulatory Exclusivity Expiration:Jan 23, 2021
Regulatory Exclusivity Use:REVISED DOSING TO INCLUDE UP-TITRATION AS A STRATEGY TO IMPROVE TOLERABILITY AND THEREBY REDUCE TREATMENT DISCONTINUATION FOR ROFLUMILAST MAINTENANCE DOSAGE OF 500 MCG DAILY
Patent:➤ Try a Free TrialPatent Expiration:Jan 27, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT TO REDUCE THE RISK OF COPD EXACERBATIONS IN PATIENTS WITH SEVERE COPD ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS

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