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Serving leading biopharmaceutical companies globally:

Argus Health
Federal Trade Commission
Daiichi Sankyo
Queensland Health
US Army
US Department of Justice

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076831

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NDA 076831 describes FLAVOXATE HYDROCHLORIDE, which is a drug marketed by Epic Pharma, Impax Pharms, and Paddock Llc, and is included in three NDAs. It is available from eight suppliers. Additional details are available on the FLAVOXATE HYDROCHLORIDE profile page.

The generic ingredient in FLAVOXATE HYDROCHLORIDE is flavoxate hydrochloride. There are eight drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the flavoxate hydrochloride profile page.
Summary for 076831
Applicant:Paddock Llc
Ingredient:flavoxate hydrochloride
Therapeutic Class:Genitourinary Agents
Pharmacology for NDA: 076831
Medical Subject Heading (MeSH) Categories for 076831
Suppliers and Packaging for NDA: 076831
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLAVOXATE HYDROCHLORIDE flavoxate hydrochloride TABLET;ORAL 076831 ANDA Paddock Laboratories, LLC 0574-0115 0574-0115-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0574-0115-01)
FLAVOXATE HYDROCHLORIDE flavoxate hydrochloride TABLET;ORAL 076831 ANDA Carilion Materials Management 68151-3826 68151-3826-0 1 TABLET, FILM COATED in 1 PACKAGE (68151-3826-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 16, 2004TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Argus Health
Federal Trade Commission
Fish and Richardson
Daiichi Sankyo

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