Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208065

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TAGRISSO (OSIMERTINIB MESYLATE)
EQ 40MG BASE
Marketing Status: Prescription
Active Ingredient: OSIMERTINIB MESYLATE
Proprietary Name: TAGRISSO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208065
Product Number: 001
Approval Date: Nov 13, 2015
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information
TAGRISSO (OSIMERTINIB MESYLATE)
EQ 80MG BASE
Marketing Status: Prescription
Active Ingredient: OSIMERTINIB MESYLATE
Proprietary Name: TAGRISSO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 80MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208065
Product Number: 002
Approval Date: Nov 13, 2015
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information

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