Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 206634
Company: AKORN
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
06/09/2016 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/14/2018 SUPPL-1 Labeling-Package Insert

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English