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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213994
Company: OPERAND PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
EPHEDRINE SULFATE 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
10/16/2020 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)
Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213994Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213994Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/22/2022 SUPPL-4 Manufacturing (CMC)-Packaging Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213994s004lbl.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/22/2022 SUPPL-4 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213994s004lbl.pdf
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