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Abbreviated New Drug Application (ANDA): 205473
Company: ENDO OPERATIONS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ETHACRYNATE SODIUM ETHACRYNATE SODIUM EQ 50MG BASE/VIAL 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
07/29/2015 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205473Orig1s000ltr.pdf

ETHACRYNATE SODIUM

INJECTABLE;INJECTION; EQ 50MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EDECRIN ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 016093 BAUSCH
ETHACRYNATE SODIUM ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 205473 ENDO OPERATIONS
ETHACRYNATE SODIUM ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204634 MYLAN INSTITUTIONAL
ETHACRYNATE SODIUM ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 208663 STERIMAX
ETHACRYNATE SODIUM ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207758 ZYDUS PHARMS
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