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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 208040

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DABIGATRAN ETEXILATE MESYLATE (DABIGATRAN ETEXILATE MESYLATE)
EQ 75MG BASE
Marketing Status: Prescription
Active Ingredient: DABIGATRAN ETEXILATE MESYLATE
Proprietary Name: DABIGATRAN ETEXILATE MESYLATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 75MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208040
Product Number: 001
Approval Date: Mar 11, 2020
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
DABIGATRAN ETEXILATE MESYLATE (DABIGATRAN ETEXILATE MESYLATE)
EQ 150MG BASE
Marketing Status: Prescription
Active Ingredient: DABIGATRAN ETEXILATE MESYLATE
Proprietary Name: DABIGATRAN ETEXILATE MESYLATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208040
Product Number: 002
Approval Date: Mar 11, 2020
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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