FDA ANDA · ANDA062733

MYKACET

Sponsor: COSETTE PHARMS NC

APPLICATION

ANDA062733

TYPE

ANDA

ORIGINAL APPROVAL

1987-03-06

LATEST ACTION

2001-05-30

ROUTE

TOPICAL

DOSAGE FORM

OINTMENT

MARKETING STATUS

Discontinued

Products

MYKACETDiscontinued

NYSTATIN 100,000 UNITS/GM, TRIAMCINOLONE ACETONIDE 0.1% · OINTMENT · TOPICAL

2001-05-30Manufacturing (CMC) · Supplement 12AP

2000-12-29Manufacturing (CMC) · Supplement 11AP

1996-06-28Manufacturing (CMC) · Supplement 10AP

1996-04-25Manufacturing (CMC) · Supplement 6AP

1996-04-25Manufacturing (CMC) · Supplement 4AP

1996-04-25Manufacturing (CMC) · Supplement 9AP

1996-04-25Manufacturing (CMC) · Supplement 7AP

1996-04-25Manufacturing (CMC) · Supplement 5AP

1996-02-07Manufacturing (CMC) · Supplement 8AP

1994-05-09Labeling · Supplement 3AP

1989-09-18Manufacturing (CMC) · Supplement 2AP

1987-03-06OriginalAP

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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