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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075137
Company: PHARM ASSOC

Products on ANDA 075137

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075137

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/18/1998	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75137ltr.pdf

Therapeutic Equivalents for ANDA 075137

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	074520	LANNETT CO INC
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG/5ML	SYRUP;ORAL	Prescription	No	AA	075137	PHARM ASSOC

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