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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209478

Marketing Status: Prescription
Active Ingredient: SPIRONOLACTONE
Proprietary Name: CAROSPIR
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 25MG/5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N209478
Product Number: 001
Approval Date: Aug 4, 2017
Applicant Holder Full Name: CMP DEVELOPMENT LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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