Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213536
Company: ETON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REZIPRES EPHEDRINE HYDROCHLORIDE 23.5MG/5ML (4.7MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
REZIPRES EPHEDRINE HYDROCHLORIDE 47MG/ML (47MG/ML) SOLUTION;INTRAVENOUS Discontinued None Yes No
REZIPRES EPHEDRINE HYDROCHLORIDE 47MG/5ML (9.4MG/ML) SOLUTION;INTRAVENOUS Discontinued None Yes 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
06/14/2021 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213536s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213536Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213536Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/14/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213536s000lbl.pdf

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