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Last Updated: July 10, 2020

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Details for New Drug Application (NDA): 020579


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NDA 020579 describes FLOMAX, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from two suppliers. Additional details are available on the FLOMAX profile page.

The generic ingredient in FLOMAX is tamsulosin hydrochloride. There are thirty-three drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the tamsulosin hydrochloride profile page.
Summary for 020579
Tradename:FLOMAX
Applicant:Sanofi Aventis Us
Ingredient:tamsulosin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020579
Mechanism of ActionAdrenergic alpha-Antagonists
Suppliers and Packaging for NDA: 020579
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLOMAX tamsulosin hydrochloride CAPSULE;ORAL 020579 NDA sanofi-aventis U.S. LLC 0024-5837 0024-5837-01 100 CAPSULE in 1 BOTTLE (0024-5837-01)
FLOMAX tamsulosin hydrochloride CAPSULE;ORAL 020579 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0058 0597-0058-01 100 CAPSULE in 1 BOTTLE (0597-0058-01)
Paragraph IV (Patent) Challenges for 020579
Tradename Dosage Ingredient NDA Submissiondate
FLOMAX CAPSULE;ORAL tamsulosin hydrochloride 020579 2004-12-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.4MG
Approval Date:Apr 15, 1997TE:ABRLD:Yes

Expired US Patents for NDA 020579

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us FLOMAX tamsulosin hydrochloride CAPSULE;ORAL 020579-001 Apr 15, 1997   Start Trial   Start Trial
Sanofi Aventis Us FLOMAX tamsulosin hydrochloride CAPSULE;ORAL 020579-001 Apr 15, 1997   Start Trial   Start Trial
Sanofi Aventis Us FLOMAX tamsulosin hydrochloride CAPSULE;ORAL 020579-001 Apr 15, 1997   Start Trial   Start Trial
Sanofi Aventis Us FLOMAX tamsulosin hydrochloride CAPSULE;ORAL 020579-001 Apr 15, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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