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Abbreviated New Drug Application (ANDA): 065384
Company: CHARTWELL

• Other Important Information from FDA

Products on ANDA 065384

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLARITHROMYCIN	CLARITHROMYCIN	250MG	TABLET;ORAL	Prescription	AB	No	No
CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065384

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/20/2007	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-17	Labeling-Package Insert		Label is not available on this site.
03/07/2023	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
03/07/2023	SUPPL-14	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/07/2023	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/07/2023	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
03/07/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
03/07/2023	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
07/27/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
07/27/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/27/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
03/06/2013	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
07/18/2012	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
11/06/2008	SUPPL-4	Labeling		Label is not available on this site.
07/16/2008	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065384

CLARITHROMYCIN

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLARITHROMYCIN	CLARITHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	210459	ALEMBIC
CLARITHROMYCIN	CLARITHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	065489	AUROBINDO
CLARITHROMYCIN	CLARITHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	065384	CHARTWELL
CLARITHROMYCIN	CLARITHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	203584	HEC PHARM
CLARITHROMYCIN	CLARITHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	065144	SANDOZ
CLARITHROMYCIN	CLARITHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	202710	STRIDES PHARMA

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