Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021588

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GLEEVEC (IMATINIB MESYLATE)
EQ 100MG BASE Marketing Status: Prescription

Active Ingredient: IMATINIB MESYLATE
Proprietary Name: GLEEVEC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021588
Product Number: 001
Approval Date: Apr 18, 2003
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

GLEEVEC (IMATINIB MESYLATE)
EQ 400MG BASE Marketing Status: Prescription

Active Ingredient: IMATINIB MESYLATE
Proprietary Name: GLEEVEC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 400MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021588
Product Number: 002
Approval Date: Apr 18, 2003
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

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