FDA NDA · NDA019259

FLORONE E

Sponsor: PFIZER

APPLICATION

NDA019259

TYPE

NDA

ORIGINAL APPROVAL

1985-08-28

LATEST ACTION

2017-10-25

ROUTE

TOPICAL

DOSAGE FORM

CREAM

MARKETING STATUS

Discontinued

Products

FLORONE EDiscontinued

DIFLORASONE DIACETATE 0.05% · CREAM · TOPICAL

2017-10-25Labeling · Supplement 12 · standard — Label ↗AP

2003-05-29Labeling · Supplement 9 · standard — Letter ↗AP

1999-01-21Manufacturing (CMC) · Supplement 8 · standardAP

1997-10-10Manufacturing (CMC) · Supplement 7 · standardAP

1996-05-17Manufacturing (CMC) · Supplement 6 · standardAP

1993-03-25Manufacturing (CMC) · Supplement 4 · standardAP

1986-10-14Labeling · Supplement 2AP

1986-08-26Manufacturing (CMC) · Supplement 3 · standardAP

1986-03-12Manufacturing (CMC) · Supplement 1 · standardAP

1985-08-28Type 3 - New Dosage Form · 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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