Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208289
Company: FLAMEL IRELAND LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AKOVAZ EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/29/2016 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208289s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208289Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208289Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208289Orig1s000SumR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/29/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208289s000lbl.pdf

AKOVAZ

SOLUTION;INTRAVENOUS; 50MG/ML (50MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AKOVAZ EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 208289 FLAMEL IRELAND LTD
EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 208609 AKORN INC
EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 209784 SANDOZ INC

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