FLAVOXATE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for flavoxate hydrochloride and what is the scope of freedom to operate?

Flavoxate hydrochloride is the generic ingredient in two branded drugs marketed by Epic Pharma, Impax Pharms, Padagis Us, and Ortho Mcneil Janssen, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for flavoxate hydrochloride. Three suppliers are listed for this compound.

Summary for FLAVOXATE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	3
Patent Applications:	1,622
What excipients (inactive ingredients) are in FLAVOXATE HYDROCHLORIDE?	FLAVOXATE HYDROCHLORIDE excipients list
DailyMed Link:	FLAVOXATE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for FLAVOXATE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Calgary	Phase 4
Mahidol University	Phase 4
Paddock Laboratories, Inc.	Phase 1

See all FLAVOXATE HYDROCHLORIDE clinical trials

Pharmacology for FLAVOXATE HYDROCHLORIDE

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Medical Subject Heading (MeSH) Categories for FLAVOXATE HYDROCHLORIDE

Parasympatholytics
Urological Agents

Anatomical Therapeutic Chemical (ATC) Classes for FLAVOXATE HYDROCHLORIDE

G04BD	Drugs for urinary frequency and incontinence
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for FLAVOXATE HYDROCHLORIDE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ortho Mcneil Janssen	URISPAS	flavoxate hydrochloride	TABLET;ORAL	016769-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Pharms	FLAVOXATE HYDROCHLORIDE	flavoxate hydrochloride	TABLET;ORAL	076234-001	Aug 28, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Us	FLAVOXATE HYDROCHLORIDE	flavoxate hydrochloride	TABLET;ORAL	076831-001	Dec 16, 2004	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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