FDA NDA · NDA022202

ZIPSOR

diclofenac potassium

Sponsor: COSETTE

APPLICATION

NDA022202

TYPE

NDA

ORIGINAL APPROVAL

2009-06-16

LATEST ACTION

2024-11-21

ROUTE

ORAL

DOSAGE FORM

CAPSULE

MARKETING STATUS

Prescription

Products

ZIPSOR · ReferencePrescription

DICLOFENAC POTASSIUM 25MG · CAPSULE · ORAL

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

2021-05-25Labeling · Supplement 14 · standard — Letter ↗AP

2021-05-25Efficacy · Supplement 13 · standard — Letter ↗AP

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

2015-12-16Labeling · Supplement 10 · standardAP

2015-08-07Manufacturing (CMC) · Supplement 8 · standardAP

2011-05-04REMS · Supplement 3 — Letter ↗AP

2011-05-04REMS · Supplement 4 — Letter ↗AP

2009-06-16Type 3 - New Dosage Form · 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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