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FDA NDA · NDA203826

PHENYLEPHRINE HYDROCHLORIDE

Sponsor: HIKMA

APPLICATION
NDA203826
TYPE
NDA
ORIGINAL APPROVAL
2012-12-20
LATEST ACTION
2023-03-09
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

IMMPHENTIV · ReferencePrescription
PHENYLEPHRINE HYDROCHLORIDE 0.5MG/5ML (0.1MG/ML) · SOLUTION · INTRAVENOUS
PHENYLEPHRINE HYDROCHLORIDE · ReferencePrescription
PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) · SOLUTION · INTRAVENOUS
IMMPHENTIV · ReferencePrescription
PHENYLEPHRINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) · SOLUTION · INTRAVENOUS
PHENYLEPHRINE HYDROCHLORIDE · ReferencePrescription
PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) · SOLUTION · INTRAVENOUS
PHENYLEPHRINE HYDROCHLORIDE · ReferencePrescription
PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2023-03-09Labeling · Supplement 17 · standard — Letter ↗AP
2023-03-09Manufacturing (CMC) · Supplement 15 — Letter ↗AP
2019-06-19Manufacturing (CMC) · Supplement 9 · standard — Label ↗AP
2016-12-09Manufacturing (CMC) · Supplement 6 · standardAP
2016-09-06Labeling · Supplement 2 · standard — Letter ↗AP
2015-02-16Manufacturing (CMC) · Supplement 5 · standardAP
2014-10-23Manufacturing (CMC) · Supplement 3 · standardAP
2012-12-20Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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