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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206121
Company: UNIQUE

Products on ANDA 206121

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206121

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/27/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/24/2023	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
02/28/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
08/19/2019	SUPPL-3	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
08/19/2019	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206121

OXYBUTYNIN CHLORIDE

TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL	Prescription	No	AB	207138	ACCORD HLTHCARE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211655	AJANTA PHARMA LTD
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204010	AMNEAL PHARMS
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	210717	BIONPHARMA
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078503	OSMOTICA PHARM US
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214415	RUBICON
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206121	UNIQUE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202332	ZYDUS PHARMS

TABLET, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207138	ACCORD HLTHCARE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211655	AJANTA PHARMA LTD
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204010	AMNEAL PHARMS
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	210717	BIONPHARMA
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078503	OSMOTICA PHARM US
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214415	RUBICON
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206121	UNIQUE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202332	ZYDUS PHARMS

TABLET, EXTENDED RELEASE;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207138	ACCORD HLTHCARE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211655	AJANTA PHARMA LTD
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204010	AMNEAL PHARMS
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	210717	BIONPHARMA
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078503	OSMOTICA PHARM US
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214415	RUBICON
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206121	UNIQUE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202332	ZYDUS PHARMS

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