Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212614
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIJARDY XR EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE 5MG;2.5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
TRIJARDY XR EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE 10MG;5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
TRIJARDY XR EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE 12.5MG;2.5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
TRIJARDY XR EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE 25MG;5MG;1GM TABLET, EXTENDED RELEASE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/27/2020 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212614s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212614Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/27/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212614s000lbl.pdf

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