Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213550
Company: REGCON HOLDINGS

Products on ANDA 213550

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 213550

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/14/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213550

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	074625	AIPING PHARM INC
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	211682	HERITAGE PHARMA AVET
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	213550	REGCON HOLDINGS
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	209025	RISING
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	208165	STRIDES PHARMA
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	075079	STRIDES PHARMA INTL
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	TP ANDA HOLDINGS