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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 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 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

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 0310-0095 0310-0095-30 30 TABLET in 1 BOTTLE, PLASTIC (0310-0095-30)
DALIRESP
roflumilast
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?
Patent:9,468,598Patent Expiration:Feb 19, 2023Product Flag?YSubstance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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