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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076831
Company: PADAGIS US

Products on ANDA 076831

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLAVOXATE HYDROCHLORIDE	FLAVOXATE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076831

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/2004	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 076831

FLAVOXATE HYDROCHLORIDE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLAVOXATE HYDROCHLORIDE	FLAVOXATE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	076835	EPIC PHARMA
FLAVOXATE HYDROCHLORIDE	FLAVOXATE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	076831	PADAGIS US

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