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Diclofenac Sodium Topical

FDA Drug Profile — Diclofenac Sodium, Diclofenac Sodium 1.5%

Drug Details

Generic Name
Diclofenac Sodium Topical
Brand Names
Diclofenac Sodium, Diclofenac Sodium 1.5%
Application Number
ANDA212351
Sponsor
REMEDYREPACK INC.
NDC Codes
13
Dosage Forms
GEL, SOLUTION
Routes
TOPICAL
Active Ingredients
DICLOFENAC SODIUM

Indications and Usage

1 INDICATIONS AND USAGE Diclofenac sodium topical gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. Diclofenac sodium topical gel has not been evaluated for use on the spine, hip, or shoulder. Diclofenac sodium topical gel is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. Diclofenac sodium topical gel was not evaluated for use on joints of the spine, hip, or shoulder. (14.1)