Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 211809
Company: AGNITIO
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
07/12/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

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 205709 ALVOGEN
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 208805 AMNEAL PHARMS CO
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 205609 EDENBRIDGE PHARMS
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 208501 PAR PHARM INC
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 207262 WEST-WARD PHARMS INT

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