Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022206

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RAPAFLO (SILODOSIN)
4MG
Marketing Status: Prescription

Active Ingredient: SILODOSIN
Proprietary Name: RAPAFLO
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 4MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022206
Product Number: 001
Approval Date: Oct 8, 2008
Applicant Holder Full Name: ALLERGAN SALES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

RAPAFLO (SILODOSIN)
8MG
Marketing Status: Prescription

Active Ingredient: SILODOSIN
Proprietary Name: RAPAFLO
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 8MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022206
Product Number: 002
Approval Date: Oct 8, 2008
Applicant Holder Full Name: ALLERGAN SALES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information