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 two 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-five suppliers are listed for this compound. Additional details are available on the diclofenac sodium 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-five 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 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022122
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased 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: | OTC | Dosage: | GEL;TOPICAL | Strength | 1% | ||||
| Approval Date: | Oct 17, 2007 | TE: | RLD: | Yes | |||||
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