FDA NDA · NDA020706

EMADINE

Sponsor: NOVARTIS

APPLICATION

NDA020706

TYPE

NDA

ORIGINAL APPROVAL

1997-12-29

LATEST ACTION

2003-05-12

ROUTE

OPHTHALMIC

DOSAGE FORM

SOLUTION/DROPS

MARKETING STATUS

Discontinued

Products

EMADINE · ReferenceDiscontinued

EMEDASTINE DIFUMARATE 0.05% · SOLUTION/DROPS · OPHTHALMIC

2003-05-12Labeling · Supplement 11 · standard — Label ↗AP

2002-12-04Manufacturing (CMC) · Supplement 10 · standardAP

2002-03-13Manufacturing (CMC) · Supplement 9 · standardAP

2001-03-16Manufacturing (CMC) · Supplement 8 · standardAP

2000-02-18Manufacturing (CMC) · Supplement 7 · standardAP

1999-12-20Manufacturing (CMC) · Supplement 6 · standardAP

1999-09-28Manufacturing (CMC) · Supplement 4 · standardAP

1999-08-17Manufacturing (CMC) · Supplement 5 · standardAP

1999-02-05Manufacturing (CMC) · Supplement 3 · standardAP

1999-01-04Manufacturing (CMC) · Supplement 1 · standardAP

1998-08-04Manufacturing (CMC) · Supplement 2 · standardAP

1997-12-29Type 1 - New Molecular Entity · Original · standard — Review ↗AP

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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