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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078503
Company: OSMOTICA PHARM US

Products on ANDA 078503

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 078503

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/04/2009	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078503Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/09/2019	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
09/09/2019	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
11/04/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
11/04/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
08/30/2013	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
08/30/2013	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/07/2010	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078503

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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