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FDA NDA · NDA020191

ALOMIDE

Sponsor: NOVARTIS

APPLICATION
NDA020191
TYPE
NDA
ORIGINAL APPROVAL
1993-09-23
LATEST ACTION
2003-06-26
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

ALOMIDE · ReferenceDiscontinued
LODOXAMIDE TROMETHAMINE EQ 0.1% BASE · SOLUTION/DROPS · OPHTHALMIC

Approval history

2003-06-26Labeling · Supplement 18 · standard — Letter ↗AP
2002-12-04Manufacturing (CMC) · Supplement 17 · standardAP
2002-09-05Manufacturing (CMC) · Supplement 16 · standardAP
2002-03-13Manufacturing (CMC) · Supplement 15 · standardAP
2001-03-16Manufacturing (CMC) · Supplement 14 · standardAP
2000-02-18Manufacturing (CMC) · Supplement 13 · standardAP
1999-09-28Manufacturing (CMC) · Supplement 11 · standardAP
1999-08-17Manufacturing (CMC) · Supplement 12 · standardAP
1999-04-07Manufacturing (CMC) · Supplement 10 · standardAP
1999-03-11Manufacturing (CMC) · Supplement 8 · standardAP
1999-02-05Manufacturing (CMC) · Supplement 9 · standardAP
1998-08-04Manufacturing (CMC) · Supplement 7 · standardAP
1998-03-31Manufacturing (CMC) · Supplement 6 · standardAP
1997-04-09Manufacturing (CMC) · Supplement 5 · standardAP
1996-12-17Manufacturing (CMC) · Supplement 4 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 3 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 2 · standardAP
1995-03-13Labeling · Supplement 1 · standardAP
1993-09-23Type 1 - New Molecular Entity · Original · standardAP
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