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FDA NDA · NDA021009

ALOCRIL

Sponsor: ALLERGAN

APPLICATION
NDA021009
TYPE
NDA
ORIGINAL APPROVAL
1999-12-08
LATEST ACTION
2016-01-13
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

ALOCRIL · ReferenceDiscontinued
NEDOCROMIL SODIUM 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC

Approval history

2016-01-13Manufacturing (CMC) · Supplement 11 · priorityAP
2008-07-07Labeling · Supplement 10 · standard — Letter ↗AP
2007-08-21Manufacturing (CMC) · Supplement 3 · priority — Label ↗AP
2007-08-21Labeling · Supplement 4 · standard — Label ↗AP
2004-10-18Labeling · Supplement 9 · standard — Letter ↗AP
2004-10-18Manufacturing (CMC) · Supplement 8 · priority — Letter ↗AP
2002-03-08Manufacturing (CMC) · Supplement 2 · priority — Letter ↗AP
2000-07-18Manufacturing (CMC) · Supplement 1 · priorityAP
1999-12-08Type 3 - New Dosage Form · Original · priority — Review ↗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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