Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 016199

Marketing Status: Prescription
Active Ingredient: HYDROCORTISONE
Proprietary Name: CORTENEMA
Dosage Form; Route of Administration: ENEMA; RECTAL
Strength: 100MG/60ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N016199
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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