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FDA NDA · NDA212909

BIORPHEN

phenylephrine hydrochloride

Sponsor: DR REDDYS LABS SA

APPLICATION
NDA212909
TYPE
NDA
ORIGINAL APPROVAL
2019-10-21
LATEST ACTION
2024-04-12
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued, Prescription

Products

BIORPHEN · ReferenceDiscontinued
PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) · SOLUTION · INTRAVENOUS
BIORPHEN · ReferencePrescription
PHENYLEPHRINE HYDROCHLORIDE 0.5MG/5ML (0.1MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-04-12Manufacturing (CMC) · Supplement 2 — Letter ↗AP
2021-03-11Efficacy · Supplement 1 · standard — Label ↗AP
2019-10-21Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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