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FDA NDA · NDA208081

AMELUZ

aminolevulinic acid hydrochloride

Sponsor: BIOFRONTERA

APPLICATION
NDA208081
TYPE
NDA
ORIGINAL APPROVAL
2016-05-10
LATEST ACTION
2024-10-04
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

AMELUZ · ReferencePrescription
AMINOLEVULINIC ACID HYDROCHLORIDE 10% · GEL · TOPICAL

Approval history

2024-10-04Efficacy · Supplement 28 · standard — Letter ↗AP
2024-03-11Manufacturing (CMC) · Supplement 26 — Letter ↗AP
2021-05-25Labeling · Supplement 11 · standard — Letter ↗AP
2017-09-06Labeling · Supplement 2 · standard — Label ↗AP
2016-05-10Type 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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