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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022206

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NDA 022206 describes RAPAFLO, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the RAPAFLO profile page.

The generic ingredient in RAPAFLO is silodosin. There are twelve drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the silodosin profile page.
Summary for 022206
Tradename:RAPAFLO
Applicant:Allergan Sales Llc
Ingredient:silodosin
Patents:0
Pharmacology for NDA: 022206
Mechanism of ActionAdrenergic alpha-Antagonists
Suppliers and Packaging for NDA: 022206
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAPAFLO silodosin CAPSULE;ORAL 022206 NDA Allergan, Inc. 0023-6142 0023-6142-30 30 CAPSULE in 1 BOTTLE, UNIT-DOSE (0023-6142-30)
RAPAFLO silodosin CAPSULE;ORAL 022206 NDA Allergan, Inc. 0023-6142 0023-6142-90 90 CAPSULE in 1 BOTTLE, UNIT-DOSE (0023-6142-90)
Paragraph IV (Patent) Challenges for 022206
Tradename Dosage Ingredient NDA Submissiondate
RAPAFLO CAPSULE;ORAL silodosin 022206 2012-10-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength4MG
Approval Date:Oct 8, 2008TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength8MG
Approval Date:Oct 8, 2008TE:ABRLD:Yes

Expired US Patents for NDA 022206

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc RAPAFLO silodosin CAPSULE;ORAL 022206-001 Oct 8, 2008   Start Trial   Start Trial
Allergan Sales Llc RAPAFLO silodosin CAPSULE;ORAL 022206-001 Oct 8, 2008   Start Trial   Start Trial
Allergan Sales Llc RAPAFLO silodosin CAPSULE;ORAL 022206-001 Oct 8, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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