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Last Updated: March 5, 2024

Details for New Drug Application (NDA): 021005


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NDA 021005 describes SOLARAZE, which is a drug marketed by Fougera Pharms and is included in one NDA. Additional details are available on the SOLARAZE profile page.

The generic ingredient in SOLARAZE 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 021005
Tradename:SOLARAZE
Applicant:Fougera Pharms
Ingredient:diclofenac sodium
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:GEL;TOPICALStrength3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 16, 2000TE:RLD:Yes

Expired US Patents for NDA 021005

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000 ⤷  Try a Trial ⤷  Try a Trial
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000 ⤷  Try a Trial ⤷  Try a Trial
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000 ⤷  Try a Trial ⤷  Try a Trial
Fougera Pharms SOLARAZE diclofenac sodium GEL;TOPICAL 021005-001 Oct 16, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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