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FDA NDA · NDA020451

PHOTOFRIN

porfimer sodium

Sponsor: PINNACLE BIOLGS

APPLICATION
NDA020451
TYPE
NDA
ORIGINAL APPROVAL
1995-12-27
LATEST ACTION
2020-01-01
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PHOTOFRINPrescription
PORFIMER SODIUM 75MG/VIAL · INJECTABLE · INJECTION

Approval history

2020-01-01Labeling · Supplement 29 · standard — Letter ↗AP
2011-06-24Labeling · Supplement 23 · standard — Letter ↗AP
2011-04-04Labeling · Supplement 20 · standard — Label ↗AP
2008-09-08Efficacy · Supplement 19 · unknown — Label ↗AP
2005-09-29Labeling · Supplement 16 · standard — Letter ↗AP
2003-08-01Labeling · Supplement 12 · standard — Review ↗AP
2002-07-19Manufacturing (CMC) · Supplement 13 · priorityAP
2001-09-25Manufacturing (CMC) · Supplement 10 · priorityAP
2001-06-15Manufacturing (CMC) · Supplement 8 · priorityAP
2001-05-08Manufacturing (CMC) · Supplement 9 · priorityAP
2000-07-06Labeling · Supplement 6 · standardAP
1999-03-17Manufacturing (CMC) · Supplement 5 · priorityAP
1998-12-22Efficacy · Supplement 3 · standard — Letter ↗AP
1998-01-09Efficacy · Supplement 2 · standard — Letter ↗AP
1996-09-10Manufacturing (CMC) · Supplement 1 · priorityAP
1995-12-27Type 1 - New Molecular Entity · Original · priority — 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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