Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022512

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PRADAXA (DABIGATRAN ETEXILATE MESYLATE)
EQ 75MG BASE
Marketing Status: Prescription

Active Ingredient: DABIGATRAN ETEXILATE MESYLATE
Proprietary Name: PRADAXA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 75MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022512
Product Number: 001
Approval Date: Oct 19, 2010
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PRADAXA (DABIGATRAN ETEXILATE MESYLATE)
EQ 110MG BASE
Marketing Status: Prescription

Active Ingredient: DABIGATRAN ETEXILATE MESYLATE
Proprietary Name: PRADAXA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 110MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022512
Product Number: 003
Approval Date: Nov 20, 2015
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PRADAXA (DABIGATRAN ETEXILATE MESYLATE)
EQ 150MG BASE
Marketing Status: Prescription

Active Ingredient: DABIGATRAN ETEXILATE MESYLATE
Proprietary Name: PRADAXA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022512
Product Number: 002
Approval Date: Oct 19, 2010
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information