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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 085025

HYDROCORTISONE (HYDROCORTISONE)
2.5%
Marketing Status: Prescription
Active Ingredient: HYDROCORTISONE
Proprietary Name: HYDROCORTISONE
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 2.5%
Reference Listed Drug: No
Reference Standard: No
TE Code: AT
Application Number: A085025
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PADAGIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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