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FDA NDA · NDA021756

MACUGEN

Sponsor: BAUSCH AND LOMB INC

APPLICATION
NDA021756
TYPE
NDA
ORIGINAL APPROVAL
2004-09-17
LATEST ACTION
2017-01-26
ROUTE
INTRAVITREAL
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

MACUGEN · ReferenceDiscontinued
PEGAPTANIB SODIUM EQ 0.3MG ACID/0.09ML · INJECTABLE · INTRAVITREAL

Approval history

2017-01-26Manufacturing (CMC) · Supplement 20 · standardAP
2011-10-12Labeling · Supplement 18 · unknown — Label ↗AP
2008-04-08Manufacturing (CMC) · Supplement 12AP
2006-03-08Labeling · Supplement 7 · standard — Label ↗AP
2006-03-08Labeling · Supplement 6 · standard — Label ↗AP
2005-11-17Manufacturing (CMC) · Supplement 5 · priority — Letter ↗AP
2005-11-17Labeling · Supplement 4 · standard — Letter ↗AP
2004-09-17Type 1 - New Molecular Entity · Original · priority — Letter ↗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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