Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074520
Company: LANNETT CO INC

Products on ANDA 074520

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074520

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/29/1996	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2011	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/20/2010	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
07/11/2001	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/04/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/04/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074520

OXYBUTYNIN CHLORIDE

SYRUP;ORAL; 5MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP;ORAL	Prescription	No	AA	075039	CHARTWELL RX
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP;ORAL	Prescription	No	AA	074520	LANNETT CO INC