Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065136
Company: SANDOZ

• Other Important Information from FDA

Products on ANDA 065136

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065136

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/25/2005	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-32	Labeling-Package Insert		Label is not available on this site.
05/18/2023	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
05/18/2023	SUPPL-27	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/18/2023	SUPPL-25	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/18/2023	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
05/18/2023	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
07/01/2015	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
07/01/2015	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
07/01/2015	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
12/11/2012	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
08/22/2008	SUPPL-11	Labeling		Label is not available on this site.
04/09/2008	SUPPL-7	Labeling		Label is not available on this site.
10/17/2007	SUPPL-6	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065136

CLARITHROMYCIN

TABLET;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;ORAL	Prescription	No	AB	210459	ALEMBIC
CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	065489	AUROBINDO
CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	065384	CHARTWELL
CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	203584	HEC PHARM
CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	065136	SANDOZ
CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	202710	STRIDES PHARMA