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Details for New Drug Application (NDA): 203975

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NDA 203975 describes ANORO ELLIPTA, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the ANORO ELLIPTA profile page.

The generic ingredient in ANORO ELLIPTA is umeclidinium bromide; vilanterol trifenatate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the umeclidinium bromide; vilanterol trifenatate profile page.

Summary for NDA: 203975

Pharmacology for NDA: 203975

Suppliers and Packaging for NDA: 203975

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANORO ELLIPTA
umeclidinium bromide; vilanterol trifenatate
POWDER;INHALATION 203975 NDA GlaxoSmithKline LLC 0173-0869 0173-0869-06 1 TRAY in 1 CARTON (0173-0869-06) > 1 INHALER in 1 TRAY > 7 POWDER in 1 INHALER
ANORO ELLIPTA
umeclidinium bromide; vilanterol trifenatate
POWDER;INHALATION 203975 NDA GlaxoSmithKline LLC 0173-0869 0173-0869-10 1 TRAY in 1 CARTON (0173-0869-10) > 1 INHALER in 1 TRAY > 30 POWDER in 1 INHALER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrengthEQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
Approval Date:Dec 18, 2013TE:RLD:Yes
Patent:5,873,360Patent Expiration:Feb 23, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:7,488,827Patent Expiration:Apr 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:7,498,440Patent Expiration:Apr 27, 2025Product Flag?YSubstance Flag?YDelist Request?

Expired Orange Book Patents for NDA: 203975

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
ANORO ELLIPTA
umeclidinium bromide; vilanterol trifenatate
POWDER;INHALATION203975-001Dec 18, 20135,873,360► 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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