Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202755
Company: VIRTUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION 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
02/25/2016 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202755Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/12/2018 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

TRANEXAMIC ACID

INJECTABLE;INJECTION; 100MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYKLOKAPRON TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription Yes AP 019281 PHARMACIA AND UPJOHN
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 202436 ACIC PHARMS
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 209326 ACIC PHARMS
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 202373 AKORN
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 206594 AKORN
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 206634 AKORN
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 208840 AMNEAL PHARMS CO
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 212676 APOLLO PHARMS INC
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 205035 AUROBINDO PHARMA LTD
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 212360 CAPLIN
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 203521 EMCURE PHARMS LTD
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 091596 FRESENIUS KABI USA
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 207239 GLAND PHARMA LTD
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 201885 LUITPOLD
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 206713 MICRO LABS
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 091657 MYLAN INSTITUTIONAL
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 202755 VIRTUS PHARMS
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 201580 X-GEN PHARMS INC
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 205228 ZYDUS PHARMS

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