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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 022122


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NDA 022122 describes VOLTAREN ARTHRITIS PAIN, which is a drug marketed by Haleon Us Holdings and is included in one NDA. It is available from three suppliers. Additional details are available on the VOLTAREN ARTHRITIS PAIN profile page.

The generic ingredient in VOLTAREN ARTHRITIS PAIN is diclofenac sodium. There are forty-seven drug master file entries for this compound. One hundred and twenty-eight suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.
Summary for 022122
Tradename:VOLTAREN ARTHRITIS PAIN
Applicant:Haleon Us Holdings
Ingredient:diclofenac sodium
Patents:0
Pharmacology for NDA: 022122
Mechanism of ActionCyclooxygenase Inhibitors
Physiological EffectDecreased Prostaglandin Production
Suppliers and Packaging for NDA: 022122
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VOLTAREN ARTHRITIS PAIN diclofenac sodium GEL;TOPICAL 022122 NDA Haleon US Holdings LLC 0067-8152 0067-8152-01 1 TUBE in 1 CARTON (0067-8152-01) / 20 g in 1 TUBE
VOLTAREN ARTHRITIS PAIN diclofenac sodium GEL;TOPICAL 022122 NDA Haleon US Holdings LLC 0067-8152 0067-8152-02 1 TUBE in 1 CARTON (0067-8152-02) / 50 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:GEL;TOPICALStrength1%
Approval Date:Oct 17, 2007TE:RLD:Yes

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