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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210696
Company: EUGIA PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/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
01/07/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

PHENYLEPHRINE HYDROCHLORIDE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP2 209968 AVET LIFESCIENCES
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP2 217521 BE PHARMS
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP2 210696 EUGIA PHARMA
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP2 210665 FRESENIUS KABI USA
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP2 203826 HIKMA
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription No AP2 210334 MEITHEAL
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