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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020193

ELMIRON (PENTOSAN POLYSULFATE SODIUM)
100MG
Marketing Status: Prescription
Active Ingredient: PENTOSAN POLYSULFATE SODIUM
Proprietary Name: ELMIRON
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020193
Product Number: 001
Approval Date: Sep 26, 1996
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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