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Details for New Drug Application (NDA): 205103

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NDA 205103 describes YOSPRALA, which is a drug marketed by Aralez Pharms and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the YOSPRALA profile page.

The generic ingredient in YOSPRALA is aspirin; omeprazole. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aspirin; omeprazole profile page.

Summary for NDA: 205103

Tradename:
YOSPRALA
Applicant:
Aralez Pharms
Ingredient:
aspirin; omeprazole
Patents:3
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 205103

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
YOSPRALA
aspirin; omeprazole
TABLET, DELAYED RELEASE;ORAL 205103 NDA Aralez Pharmaceuticals Us Inc. 70347-081 70347-081-30 30 TABLET, FILM COATED in 1 BOTTLE (70347-081-30)
YOSPRALA
aspirin; omeprazole
TABLET, DELAYED RELEASE;ORAL 205103 NDA Aralez Pharmaceuticals Us Inc. 70347-081 70347-081-90 90 TABLET, FILM COATED in 1 BOTTLE (70347-081-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength81MG;40MG
Approval Date:Sep 14, 2016TE:RLD:No
Patent:6,926,907Patent Expiration:Feb 28, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:8,206,741Patent Expiration:Feb 28, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:9,364,439Patent Expiration:May 31, 2022Product 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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