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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208943
Company: PAR STERILE PRODUCTS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CORPHEDRA EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION;INTRAVENOUS 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
01/27/2017 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208943s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208943Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208943Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/27/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208943s000lbl.pdf

CORPHEDRA

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
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