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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021005

SOLARAZE (DICLOFENAC SODIUM)
3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DICLOFENAC SODIUM
Proprietary Name: SOLARAZE
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021005
Product Number: 001
Approval Date: Oct 16, 2000
Applicant Holder Full Name: FOUGERA PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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