Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202925
Company: ACCORD HLTHCARE

Products on ANDA 202925

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 75MG BASE	TABLET;ORAL	Discontinued	None	No	No
CLOPIDOGREL BISULFATE	CLOPIDOGREL BISULFATE	EQ 300MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202925

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/27/2013	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
02/11/2025	SUPPL-19	Labeling-Container/Carton Labels		Label is not available on this site.
08/29/2023	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
08/29/2023	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
09/20/2019	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
07/19/2019	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
07/19/2019	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
07/19/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/19/2019	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
11/05/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
11/05/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
11/05/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
11/05/2015	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.