← FDA DRUG APPROVALS

FDA NDA · NDA020969

UVADEX

Sponsor: THERAKOS DEVELOPMENT

APPLICATION
NDA020969
TYPE
NDA
ORIGINAL APPROVAL
1999-02-25
LATEST ACTION
2021-03-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

UVADEX · ReferencePrescription
METHOXSALEN 0.02MG/ML · INJECTABLE · INJECTION

Approval history

2021-03-19Labeling · Supplement 14 · standard — Letter ↗AP
2018-01-09Labeling · Supplement 10 · standard — Label ↗AP
2013-11-01Labeling · Supplement 6 · standard — Label ↗AP
2013-06-05Manufacturing (CMC) · Supplement 5 · standardAP
1999-02-25Type 3 - New Dosage Form · Original · standard — Review ↗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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