Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210125
Company: TULEX PHARMS INC

Products on ANDA 210125

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210125

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/06/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210125

OXYBUTYNIN CHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	209335	ABHAI LLC
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	209025	APPCO
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	213550	BEXIMCO PHARMS USA
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	212798	LEADING
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	210611	NOVAST LABS
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	209823	NOVITIUM PHARMA
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	075079	STRIDES PHARMA
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	208165	STRIDES PHARMA
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	071655	TEVA PHARMS USA
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	210125	TULEX PHARMS INC
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	074625	UPSHER SMITH LABS