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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205609
Company: EDENBRIDGE PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription AB 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
06/30/2016 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205609Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205609Orig1s000ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/30/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205609Orig1s000lbl.pdf

ETHACRYNIC ACID

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EDECRIN ETHACRYNIC ACID 25MG TABLET;ORAL Prescription Yes AB 016092 BAUSCH
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 211809 AGNITIO
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 208805 AMNEAL PHARMS CO
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 213240 CHARTWELL RX
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 205609 EDENBRIDGE PHARMS
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 211719 LUPIN LTD
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 211232 SCIEGEN PHARMS INC
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 212417 UPSHER SMITH LABS
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