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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 three suppliers. There are five 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 eight drug master file entries for this compound. Three suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the roflumilast profile page.

Summary for NDA: 022522

Astrazeneca Pharms

Pharmacology for NDA: 022522

Suppliers and Packaging for NDA: 022522

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 022522 NDA AstraZeneca Pharmaceuticals LP 0310-0095 0310-0095-30 30 TABLET in 1 BOTTLE, PLASTIC (0310-0095-30)
TABLET;ORAL 022522 NDA AstraZeneca Pharmaceuticals LP 0310-0095 0310-0095-39 10 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0095-39) > 2 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MCG
Approval Date:Feb 28, 2011TE:RLD:Yes
Patent:8,431,154Patent Expiration:Feb 19, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:8,618,142Patent Expiration:Mar 8, 2024Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Feb 28, 2016
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Expired Orange Book Patents for NDA: 022522

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
TABLET;ORAL022522-001Feb 28, 20115,712,298► subscribe
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