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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204726

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SILODOSIN (SILODOSIN)
4MG
Marketing Status: Prescription
Active Ingredient: SILODOSIN
Proprietary Name: SILODOSIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 4MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204726
Product Number: 001
Approval Date: Mar 31, 2017
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
SILODOSIN (SILODOSIN)
8MG
Marketing Status: Prescription
Active Ingredient: SILODOSIN
Proprietary Name: SILODOSIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 8MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204726
Product Number: 002
Approval Date: Mar 31, 2017
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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