Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065154
Company: DR REDDYS LABS SA

• Other Important Information from FDA

Products on ANDA 065154

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065154

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/18/2005	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
08/16/2023	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
08/17/2023	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
08/17/2023	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
08/17/2023	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
08/17/2023	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
12/16/2015	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
12/16/2015	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
12/16/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
12/16/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
12/11/2012	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
07/19/2012	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
03/28/2012	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
08/20/2010	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
10/22/2008	SUPPL-4	Labeling		Label is not available on this site.
06/30/2008	SUPPL-3	Labeling		Label is not available on this site.
05/10/2006	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065154

CLARITHROMYCIN

TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	065145	ACTAVIS LABS FL INC
CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	065154	DR REDDYS LABS SA
CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203243	NOSTRUM LABS INC
CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208987	SUNSHINE