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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217721
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EPHEDRINE SULFATE EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION;INTRAVENOUS Prescription AP3 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
10/11/2024 ORIG-1 Approval STANDARD

Label is not available on this site.

EPHEDRINE SULFATE

SOLUTION;INTRAVENOUS; 25MG/5ML (5MG/ML)
TE Code = AP3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AKOVAZ EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP3 208289 EXELA PHARMA
EPHEDRINE SULFATE EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION;INTRAVENOUS Prescription No AP3 217721 HIKMA
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