Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 201292

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GILOTRIF (AFATINIB DIMALEATE)
EQ 20MG BASE
Marketing Status: Prescription

Active Ingredient: AFATINIB DIMALEATE
Proprietary Name: GILOTRIF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N201292
Product Number: 001
Approval Date: Jul 12, 2013
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status:  Prescription
Patent and Exclusivity Information

GILOTRIF (AFATINIB DIMALEATE)
EQ 30MG BASE
Marketing Status: Prescription

Active Ingredient: AFATINIB DIMALEATE
Proprietary Name: GILOTRIF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N201292
Product Number: 002
Approval Date: Jul 12, 2013
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status:  Prescription
Patent and Exclusivity Information

GILOTRIF (AFATINIB DIMALEATE)
EQ 40MG BASE
Marketing Status: Prescription

Active Ingredient: AFATINIB DIMALEATE
Proprietary Name: GILOTRIF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N201292
Product Number: 003
Approval Date: Jul 12, 2013
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status:  Prescription
Patent and Exclusivity Information