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FDA NDA · NDA203510

PHENYLEPHRINE HYDROCHLORIDE

Sponsor: PARAGON BIOTECK

APPLICATION
NDA203510
TYPE
NDA
ORIGINAL APPROVAL
2013-03-21
LATEST ACTION
2022-12-08
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

PHENYLEPHRINE HYDROCHLORIDE · ReferencePrescription
PHENYLEPHRINE HYDROCHLORIDE 2.5% · SOLUTION/DROPS · OPHTHALMIC
PHENYLEPHRINE HYDROCHLORIDE · ReferencePrescription
PHENYLEPHRINE HYDROCHLORIDE 10% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2022-12-08Manufacturing (CMC) · Supplement 5 · standard — Label ↗AP
2020-04-17Labeling · Supplement 2 · standard — Letter ↗AP
2013-10-08Manufacturing (CMC) · Supplement 1 · priorityAP
2013-03-21Type 7 - Drug Already Marketed without Approved NDA · Original · priority — Pediatric Medical 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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