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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040091

SULFADIAZINE (SULFADIAZINE)
500MG
Marketing Status: Prescription
Active Ingredient: SULFADIAZINE
Proprietary Name: SULFADIAZINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A040091
Product Number: 001
Approval Date: Jul 29, 1994
Applicant Holder Full Name: EPIC PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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