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Details for New Drug Application (NDA): 202450

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NDA 202450 describes TUDORZA PRESSAIR, which is a drug marketed by Astrazeneca Pharms and is included in one NDA. It is available from two suppliers. There are eight patents protecting this drug. Additional details are available on the TUDORZA PRESSAIR profile page.

The generic ingredient in TUDORZA PRESSAIR is aclidinium bromide. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the aclidinium bromide profile page.

Summary for NDA: 202450

Tradename:
TUDORZA PRESSAIR
Applicant:
Astrazeneca Pharms
Ingredient:
aclidinium bromide
Patents:8

Pharmacology for NDA: 202450

Mechanism of ActionCholinergic Antagonists

Suppliers and Packaging for NDA: 202450

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION 202450 NDA AstraZeneca Pharmaceuticals LP 0310-0800 0310-0800-39 1 POUCH in 1 CARTON (0310-0800-39) > 1 INHALER in 1 POUCH > 30 INHALANT in 1 INHALER
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION 202450 NDA AstraZeneca Pharmaceuticals LP 0310-0800 0310-0800-60 1 POUCH in 1 CARTON (0310-0800-60) > 1 INHALER in 1 POUCH > 60 INHALANT in 1 INHALER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER, METERED;INHALATIONStrength0.4MG/INH
Approval Date:Jul 23, 2012TE:RLD:Yes
Patent:5,840,279Patent Expiration:Jun 21, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:6,071,498Patent Expiration:Jun 21, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:6,681,768Patent Expiration:Aug 7, 2022Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 202450

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION202450-001Jul 23, 20125,840,279► subscribe
Astrazeneca Pharms
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION202450-001Jul 23, 20126,071,498► subscribe
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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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