Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208040
Company: ALKEM LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE;ORAL Prescription AB No No
DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/11/2020 ORIG-2 Tentative Approval STANDARD

Label is not available on this site.

03/11/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208040Orig1s000ltr.pdf

DABIGATRAN ETEXILATE MESYLATE

CAPSULE;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 208040 ALKEM LABS LTD
DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 207961 HETERO LABS LTD III
PRADAXA DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE;ORAL Prescription Yes AB 022512 BOEHRINGER INGELHEIM

CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 208040 ALKEM LABS LTD
DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 207961 HETERO LABS LTD III
PRADAXA DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE;ORAL Prescription Yes AB 022512 BOEHRINGER INGELHEIM

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