← FDA DRUG APPROVALS

FDA NDA · NDA020965

LEVULAN KERASTICK

aminolevulinic acid hydrochloride

Sponsor: SUN PHARM INDS INC

APPLICATION
NDA020965
TYPE
NDA
ORIGINAL APPROVAL
1999-12-03
LATEST ACTION
2022-05-09
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

LEVULAN · ReferencePrescription
AMINOLEVULINIC ACID HYDROCHLORIDE 20% · SOLUTION · TOPICAL

Approval history

2022-05-09Labeling · Supplement 17 · standard — Letter ↗AP
2018-04-19Labeling · Supplement 16 · standard — Label ↗AP
2018-03-06Efficacy · Supplement 15 · standard — Label ↗AP
2016-01-07Manufacturing (CMC) · Supplement 14 · standardAP
2013-11-14Manufacturing (CMC) · Supplement 13 · standardAP
2010-03-12Efficacy · Supplement 7 · standard — Letter ↗AP
2009-07-17Labeling · Supplement 6 · standard — Label ↗AP
2003-07-11Manufacturing (CMC) · Supplement 4 · standard — Letter ↗AP
2003-06-27Labeling · Supplement 3 · standard — Letter ↗AP
2003-03-26Labeling · Supplement 2 · standard — Letter ↗AP
2001-07-27Manufacturing (CMC) · Supplement 1 · standardAP
1999-12-03Type 1 - New Molecular Entity · Original · standard — Letter ↗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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