Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077665
Company: RISING

Products on ANDA 077665

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 077665

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/17/2012	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077665Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/15/2022	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/01/2019	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/26/2019	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/26/2019	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/26/2019	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/26/2019	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/11/2019	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/29/2016	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/29/2016	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
02/29/2016	SUPPL-3	Labeling-Medication Guide		Label is not available on this site.
02/29/2016	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.