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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202968
Company: WATSON LABS INC

Products on ANDA 202968

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;10MG	TABLET;ORAL	Prescription	AB	No	No
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;20MG	TABLET;ORAL	Prescription	AB	No	No
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;40MG	TABLET;ORAL	Prescription	AB	No	No
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;80MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202968

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/26/2017	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/01/2021	SUPPL-5	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
01/24/2020	SUPPL-4	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/16/2019	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/16/2019	SUPPL-2	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202968

EZETIMIBE AND SIMVASTATIN

TABLET;ORAL; 10MG;10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;10MG	TABLET;ORAL	Prescription	No	AB	209222	ALKEM LABS LTD
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;10MG	TABLET;ORAL	Prescription	No	AB	208831	AMNEAL PHARMS CO
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;10MG	TABLET;ORAL	Prescription	No	AB	200082	AUROBINDO PHARMA USA
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;10MG	TABLET;ORAL	Prescription	No	AB	200909	DR REDDYS LABS SA
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;10MG	TABLET;ORAL	Prescription	No	AB	208699	GLENMARK PHARMS LTD
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;10MG	TABLET;ORAL	Prescription	No	AB	202968	WATSON LABS INC
VYTORIN	EZETIMIBE; SIMVASTATIN	10MG;10MG	TABLET;ORAL	Prescription	Yes	AB	021687	ORGANON

TABLET;ORAL; 10MG;20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;20MG	TABLET;ORAL	Prescription	No	AB	209222	ALKEM LABS LTD
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;20MG	TABLET;ORAL	Prescription	No	AB	208831	AMNEAL PHARMS CO
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;20MG	TABLET;ORAL	Prescription	No	AB	200082	AUROBINDO PHARMA USA
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;20MG	TABLET;ORAL	Prescription	No	AB	200909	DR REDDYS LABS SA
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;20MG	TABLET;ORAL	Prescription	No	AB	208699	GLENMARK PHARMS LTD
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;20MG	TABLET;ORAL	Prescription	No	AB	202968	WATSON LABS INC
VYTORIN	EZETIMIBE; SIMVASTATIN	10MG;20MG	TABLET;ORAL	Prescription	Yes	AB	021687	ORGANON

TABLET;ORAL; 10MG;40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;40MG	TABLET;ORAL	Prescription	No	AB	209222	ALKEM LABS LTD
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;40MG	TABLET;ORAL	Prescription	No	AB	208831	AMNEAL PHARMS CO
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;40MG	TABLET;ORAL	Prescription	No	AB	200082	AUROBINDO PHARMA USA
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;40MG	TABLET;ORAL	Prescription	No	AB	200909	DR REDDYS LABS SA
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;40MG	TABLET;ORAL	Prescription	No	AB	208699	GLENMARK PHARMS LTD
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;40MG	TABLET;ORAL	Prescription	No	AB	202968	WATSON LABS INC
VYTORIN	EZETIMIBE; SIMVASTATIN	10MG;40MG	TABLET;ORAL	Prescription	Yes	AB	021687	ORGANON

TABLET;ORAL; 10MG;80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;80MG	TABLET;ORAL	Prescription	No	AB	209222	ALKEM LABS LTD
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;80MG	TABLET;ORAL	Prescription	No	AB	208831	AMNEAL PHARMS CO
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;80MG	TABLET;ORAL	Prescription	No	AB	200082	AUROBINDO PHARMA USA
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;80MG	TABLET;ORAL	Prescription	No	AB	200909	DR REDDYS LABS SA
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;80MG	TABLET;ORAL	Prescription	No	AB	208699	GLENMARK PHARMS LTD
EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;80MG	TABLET;ORAL	Prescription	No	AB	202968	WATSON LABS INC
VYTORIN	EZETIMIBE; SIMVASTATIN	10MG;80MG	TABLET;ORAL	Prescription	Yes	AB	021687	ORGANON

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