Product Details for NDA 214358
PRADAXA (DABIGATRAN ETEXILATE MESYLATE)
EQ 20MG BASE/PACKET
Marketing Status: Prescription
EQ 30MG BASE/PACKET
Marketing Status: Prescription
EQ 40MG BASE/PACKET
Marketing Status: Prescription
EQ 50MG BASE/PACKET
Marketing Status: Prescription
EQ 110MG BASE/PACKET
Marketing Status: Prescription
EQ 150MG BASE/PACKET
Marketing Status: Prescription
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)
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
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)
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
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)
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
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)
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
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)
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
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
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