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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212020
Company: EXELA PHARMA

Products on NDA 212020

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	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212020

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/15/2019	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212020Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212020Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/16/2020	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212020s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212020Orig1s003ltr.pdf

Labels for NDA 212020

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/16/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212020s003lbl.pdf
04/15/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212020lbl.pdf

Therapeutic Equivalents for NDA 212020

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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