U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 208289
Company: EXELA PHARMA
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
AKOVAZ EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION;INTRAVENOUS Prescription None 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
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/02/2021 SUPPL-6 Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208289Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208289Orig1s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/208289Orig1s006.pdf
04/08/2020 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208289s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208289Orig1s005ltr.pdf
08/10/2018 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208289s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208289Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/02/2021 SUPPL-6 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208289Orig1s006lbl.pdf
04/08/2020 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208289s005lbl.pdf
08/10/2018 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208289s002lbl.pdf
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 EXELA PHARMA
CORPHEDRA EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 208943 PAR STERILE PRODUCTS
EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 215825 AGGREGA
EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 208609 AKORN
EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 212932 AMNEAL
EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 212649 DR REDDYS
EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 214579 EUGIA PHARMA
EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 209646 FRESENIUS KABI USA
EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 216146 GLAND PHARMA LTD
EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 214334 HIKMA
EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 216129 MANKIND PHARMA
EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 209784 SANDOZ INC
Back to Top