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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203826
Company: HIKMA

Summary Review

Products on NDA 203826

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203826

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
03/09/2023	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203826Orig1s015,017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203826Orig1s015,017ltr.pdf
03/09/2023	SUPPL-15	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203826Orig1s015,017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203826Orig1s015,017ltr.pdf
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

Labels for NDA 203826

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/09/2023	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203826Orig1s015,017lbl.pdf
03/09/2023	SUPPL-15	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203826Orig1s015,017lbl.pdf
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

Therapeutic Equivalents for NDA 203826

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	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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