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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205832

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OFEV (NINTEDANIB ESYLATE)
EQ 100MG BASE
Marketing Status: Prescription
Active Ingredient: NINTEDANIB ESYLATE
Proprietary Name: OFEV
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205832
Product Number: 001
Approval Date: Oct 15, 2014
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
OFEV (NINTEDANIB ESYLATE)
EQ 150MG BASE
Marketing Status: Prescription
Active Ingredient: NINTEDANIB ESYLATE
Proprietary Name: OFEV
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205832
Product Number: 002
Approval Date: Oct 15, 2014
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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