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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219991
Company: FRESENIUS KABI USA

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 AP2 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
03/19/2026 ORIG-1 Approval STANDARD

Label is not available on this site.

EPHEDRINE SULFATE

SOLUTION;INTRAVENOUS; 50MG/10ML (5MG/ML)
TE Code = AP2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION;INTRAVENOUS Prescription No AP2 218271 FRESENIUS KABI USA
EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION;INTRAVENOUS Prescription No AP2 219991 FRESENIUS KABI USA
EPHEDRINE SULFATE EPHEDRINE SULFATE 50MG/10ML (5MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP2 213994 PH HEALTH
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