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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076274
Company: APOTEX INC

Products on ANDA 076274

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET;ORAL	Prescription	AB	No	No
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076274

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/2014	ORIG-2	Approval				Label is not available on this site.
05/17/2012	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076274Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/07/2023	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
09/07/2023	SUPPL-27	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
08/16/2021	SUPPL-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/22/2019	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/22/2019	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/22/2019	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert		Label is not available on this site.
11/22/2019	SUPPL-17	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/22/2019	SUPPL-16	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/22/2019	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
11/22/2019	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
11/22/2019	SUPPL-10	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
11/03/2014	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
03/13/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076274

CLOPIDOGREL BISULFATE

TABLET;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	202925	ACCORD HLTHCARE
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	078004	ACME LABS
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	203632	ALKEM LABS LTD
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	203751	AMNEAL PHARMS
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	076274	APOTEX INC
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	090540	AUROBINDO PHARMA LTD
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	076273	DR REDDYS
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	205345	HETERO LABS LTD V
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	202928	MACLEODS PHARMS LTD
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	213351	POLYGEN PHARMS
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	206376	PRINSTON INC
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	204359	RISING
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	204165	SCIEGEN PHARMS INC
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	076999	TEVA
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET;ORAL	Prescription	No	AB	090844	TORRENT PHARMS LTD
PLAVIX	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET;ORAL	Prescription	Yes	AB	020839	SANOFI AVENTIS US

TABLET;ORAL; EQ 300MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET;ORAL	Prescription	No	AB	202925	ACCORD HLTHCARE
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET;ORAL	Prescription	No	AB	076274	APOTEX INC
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET;ORAL	Prescription	No	AB	091023	DR REDDYS LABS LTD
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET;ORAL	Prescription	No	AB	205345	HETERO LABS LTD V
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET;ORAL	Prescription	No	AB	213351	POLYGEN PHARMS
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET;ORAL	Prescription	No	AB	206376	PRINSTON INC
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET;ORAL	Prescription	No	AB	204165	SCIEGEN PHARMS INC
PLAVIX	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET;ORAL	Prescription	Yes	AB	020839	SANOFI AVENTIS US

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