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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203826
Company: HIKMA
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 Yes Yes
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription AP2 Yes Yes
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription AP2 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
12/20/2012 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203826s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203826Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203826_phenylephrine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203826Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/19/2019 SUPPL-9 Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203826s009lbl.pdf
12/09/2016 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/16/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/23/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/06/2016 SUPPL-2 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203826s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203826Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/19/2019 SUPPL-9 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203826s009lbl.pdf
09/06/2016 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203826s002lbl.pdf
12/20/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203826s000lbl.pdf

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 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

SOLUTION;INTRAVENOUS; 50MG/5ML (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 50MG/5ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP2 203826 HIKMA

SOLUTION;INTRAVENOUS; 100MG/10ML (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 100MG/10ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP2 203826 HIKMA
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