FDA NDA · NDA050802

ZIANA

clindamycin phosphate and tretinoin

Sponsor: BAUSCH

APPLICATION

NDA050802

TYPE

NDA

ORIGINAL APPROVAL

2006-11-07

LATEST ACTION

2016-03-25

ROUTE

TOPICAL

DOSAGE FORM

GEL

MARKETING STATUS

Prescription

Products

ZIANA · ReferencePrescription

CLINDAMYCIN PHOSPHATE 1.2%, TRETINOIN 0.025% · GEL · TOPICAL

2016-03-25Manufacturing (CMC) · Supplement 17 · standardAP

2016-03-23Manufacturing (CMC) · Supplement 16 · standardAP

2013-08-20Manufacturing (CMC) · Supplement 13 · standardAP

2013-08-02Manufacturing (CMC) · Supplement 11 · standardAP

2013-07-02Manufacturing (CMC) · Supplement 14 · standardAP

2013-03-04Manufacturing (CMC) · Supplement 12 · standardAP

2006-11-07Type 4 - New Combination · 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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