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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209222
Company: ALKEM LABS LTD

Products on ANDA 209222

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 209222

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2017	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
12/16/2022	SUPPL-12	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
02/23/2021	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
01/29/2020	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/26/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/16/2019	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209222

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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