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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214358

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PRADAXA (DABIGATRAN ETEXILATE MESYLATE)
EQ 20MG BASE/PACKET
Marketing Status: Prescription
Active Ingredient: DABIGATRAN ETEXILATE MESYLATE
Proprietary Name: PRADAXA
Dosage Form; Route of Administration: PELLETS; ORAL
Strength: EQ 20MG BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214358
Product Number: 001
Approval Date: Jun 21, 2021
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PRADAXA (DABIGATRAN ETEXILATE MESYLATE)
EQ 30MG BASE/PACKET
Marketing Status: Prescription
Active Ingredient: DABIGATRAN ETEXILATE MESYLATE
Proprietary Name: PRADAXA
Dosage Form; Route of Administration: PELLETS; ORAL
Strength: EQ 30MG BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214358
Product Number: 002
Approval Date: Jun 21, 2021
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PRADAXA (DABIGATRAN ETEXILATE MESYLATE)
EQ 40MG BASE/PACKET
Marketing Status: Prescription
Active Ingredient: DABIGATRAN ETEXILATE MESYLATE
Proprietary Name: PRADAXA
Dosage Form; Route of Administration: PELLETS; ORAL
Strength: EQ 40MG BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214358
Product Number: 003
Approval Date: Jun 21, 2021
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PRADAXA (DABIGATRAN ETEXILATE MESYLATE)
EQ 50MG BASE/PACKET
Marketing Status: Prescription
Active Ingredient: DABIGATRAN ETEXILATE MESYLATE
Proprietary Name: PRADAXA
Dosage Form; Route of Administration: PELLETS; ORAL
Strength: EQ 50MG BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214358
Product Number: 004
Approval Date: Jun 21, 2021
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PRADAXA (DABIGATRAN ETEXILATE MESYLATE)
EQ 110MG BASE/PACKET
Marketing Status: Prescription
Active Ingredient: DABIGATRAN ETEXILATE MESYLATE
Proprietary Name: PRADAXA
Dosage Form; Route of Administration: PELLETS; ORAL
Strength: EQ 110MG BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214358
Product Number: 005
Approval Date: Jun 21, 2021
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
PRADAXA (DABIGATRAN ETEXILATE MESYLATE)
EQ 150MG BASE/PACKET
Marketing Status: Prescription
Active Ingredient: DABIGATRAN ETEXILATE MESYLATE
Proprietary Name: PRADAXA
Dosage Form; Route of Administration: PELLETS; ORAL
Strength: EQ 150MG BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214358
Product Number: 006
Approval Date: Jun 21, 2021
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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