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Details for New Drug Application (NDA): 208065

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NDA 208065 describes TAGRISSO, which is a drug marketed by Astrazeneca Pharms and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the TAGRISSO profile page.

The generic ingredient in TAGRISSO is osimertinib mesylate. One supplier is listed for this compound. Additional details are available on the osimertinib mesylate profile page.

Suppliers and Packaging for NDA: 208065

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAGRISSO
osimertinib mesylate
TABLET;ORAL 208065 NDA AstraZeneca Pharmaceuticals LP 0310-1349 0310-1349-30 30 TABLET, FILM COATED in 1 BOTTLE (0310-1349-30)
TAGRISSO
osimertinib mesylate
TABLET;ORAL 208065 NDA AstraZeneca Pharmaceuticals LP 0310-1350 0310-1350-30 30 TABLET, FILM COATED in 1 BOTTLE (0310-1350-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Nov 13, 2015TE:RLD:No
Regulatory Exclusivity Expiration:Nov 13, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Nov 13, 2022
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:8,946,235Patent Expiration:Aug 8, 2032Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTORE RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY


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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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