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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217155
Company: AMNEAL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRANEXAMIC ACID TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription AP 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
10/16/2023 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217155Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/01/2024 SUPPL-1 Labeling

Label is not available on this site.

TRANEXAMIC ACID

SOLUTION;INTRAVENOUS; 1GM/100ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRANEXAMIC ACID TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 217155 AMNEAL
TRANEXAMIC ACID TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 212020 EXELA PHARMA
TRANEXAMIC ACID TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 218599 GLAND PHARMA LTD
TRANEXAMIC ACID TRANEXAMIC ACID 1GM/100ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 216877 NEXUS
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