Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091023
Company: DR REDDYS LABS LTD

Products on ANDA 091023

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091023

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/2012/091023Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/16/2022	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/07/2019	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/07/2019	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/07/2019	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/07/2019	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/07/2019	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/07/2019	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/11/2016	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/17/2015	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/17/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
07/28/2015	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/17/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/04/2013	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091023

CLOPIDOGREL BISULFATE

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	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