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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018751

SPECTAZOLE (ECONAZOLE NITRATE)
1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ECONAZOLE NITRATE
Proprietary Name: SPECTAZOLE
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N018751
Product Number: 001
Approval Date: Dec 23, 1982
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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