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Details for New Drug Application (NDA): 022522
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 two Paragraph IV challenges. 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. Two suppliers are listed for this compound. Additional details are available on the roflumilast profile page.
The generic ingredient in DALIRESP is roflumilast. There are ten drug master file entries for this compound. Two 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
| Mechanism of Action | Phosphodiesterase 4 Inhibitors |
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: | RX | Dosage: | TABLET;ORAL | Strength | 500MCG | ||||
| Approval Date: | Feb 28, 2011 | TE: | AB | RLD: | 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: | See Pricing | Patent Expiration: | Jan 27, 2020 | Product Flag? | Y | Substance Flag? | Y | Delist 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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