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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 085368

PRAMOSONE (HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE)
1%;1%
Marketing Status: Prescription
Active Ingredient: HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Proprietary Name: PRAMOSONE
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 1%;1%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A085368
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SEBELA IRELAND LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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