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Details for New Drug Application (NDA): 076234

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NDA 076234 describes FLAVOXATE HYDROCHLORIDE, which is a drug marketed by Paddock Llc, Impax Pharms, and Epic Pharma, 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 NDA: 076234

Tradename:
FLAVOXATE HYDROCHLORIDE
Applicant:
Impax Pharms
Ingredient:
flavoxate hydrochloride
Patents:0
Therapeutic Class:Genitourinary Agents

Pharmacology for NDA: 076234

Suppliers and Packaging for NDA: 076234

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLAVOXATE HYDROCHLORIDE
flavoxate hydrochloride
TABLET;ORAL 076234 ANDA Global Pharmaceuticals 0115-1811 0115-1811-01 100 TABLET, FILM COATED in 1 BOTTLE (0115-1811-01)
FLAVOXATE HYDROCHLORIDE
flavoxate hydrochloride
TABLET;ORAL 076234 ANDA Global Pharmaceuticals 0115-1811 0115-1811-02 500 TABLET, FILM COATED in 1 BOTTLE (0115-1811-02)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Aug 28, 2003TE:RLD:No


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