FDA NDA · NDA019525

FML-S

Sponsor: ALLERGAN

APPLICATION

NDA019525

TYPE

NDA

ORIGINAL APPROVAL

1989-09-29

LATEST ACTION

2005-03-10

ROUTE

OPHTHALMIC

DOSAGE FORM

SUSPENSION/DROPS

MARKETING STATUS

Discontinued

Products

FML-SDiscontinued

FLUOROMETHOLONE 0.1%, SULFACETAMIDE SODIUM 10% · SUSPENSION/DROPS · OPHTHALMIC

2005-03-10Manufacturing (CMC) · Supplement 10 · standard — Letter ↗AP

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

2001-12-04Manufacturing (CMC) · Supplement 11 · standardAP

2001-04-12Manufacturing (CMC) · Supplement 9 · standardAP

2000-10-02Manufacturing (CMC) · Supplement 8 · standardAP

1998-05-01Manufacturing (CMC) · Supplement 6 · standardAP

1998-01-09Manufacturing (CMC) · Supplement 7 · standardAP

1997-09-30Manufacturing (CMC) · Supplement 5 · standardAP

1996-06-10Manufacturing (CMC) · Supplement 4 · standardAP

1995-08-03Manufacturing (CMC) · Supplement 3 · standardAP

1990-07-17Manufacturing (CMC) · Supplement 2 · standardAP

1990-07-09Manufacturing (CMC) · Supplement 1 · standardAP

1989-09-29Type 4 - New Combination · Original · standardAP

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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