FDA Drug Approval, A208040, DABIGATRAN ETEXILATE MESYLATE
FDA Drug Approval, A208040, DABIGATRAN ETEXILATE MESYLATE
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ANDA: 208040
Company: ALKEM LABS LTD
Drug Name: DABIGATRAN ETEXILATE MESYLATE
Active Ingredients: DABIGATRAN ETEXILATE MESYLATE
Strength: EQ 150MG BASE
Dosage Form/Route: CAPSULE;ORAL
Action Date: 03/11/2020
Marketing Status: Prescription
Submission Classification: ORIG-1 TE Code: AB
Company: ALKEM LABS LTD
Drug Name: DABIGATRAN ETEXILATE MESYLATE
Active Ingredients: DABIGATRAN ETEXILATE MESYLATE
Strength: EQ 150MG BASE
Dosage Form/Route: CAPSULE;ORAL
Action Date: 03/11/2020
Marketing Status: Prescription
Submission Classification: ORIG-1 TE Code: AB