FDA NDA · NDA022165

DICLOFENAC POTASSIUM

Sponsor: COSETTE

APPLICATION

NDA022165

TYPE

NDA

ORIGINAL APPROVAL

2009-06-17

LATEST ACTION

2024-11-21

ROUTE

ORAL

DOSAGE FORM

FOR SOLUTION

MARKETING STATUS

Prescription

Products

CAMBIA · ReferencePrescription

DICLOFENAC POTASSIUM 50MG · FOR SOLUTION · ORAL

2024-11-21Labeling · Supplement 16 · standard — Letter ↗AP

2024-04-23Labeling · Supplement 6 · standard — Letter ↗AP

2021-04-28Labeling · Supplement 14 · standard — Letter ↗AP

2021-04-28Labeling · Supplement 13 · standard — Letter ↗AP

2017-03-20Labeling · Supplement 12 · standard — Label ↗AP

2016-05-09Labeling · Supplement 11 · standard — Label ↗AP

2015-12-10Manufacturing (CMC) · Supplement 9 · standardAP

2014-09-30Manufacturing (CMC) · Supplement 8 · standardAP

2011-07-20REMS · Supplement 4 — Letter ↗AP

2009-06-17Type 3 - New Dosage Form · Original · standard — Label ↗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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