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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065489
Company: AUROBINDO

Products on ANDA 065489

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065489

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/25/2012	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-24	Labeling-Package Insert		Label is not available on this site.
02/14/2023	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
02/14/2023	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
02/14/2023	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
02/14/2023	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
02/14/2023	SUPPL-13	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
02/14/2023	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
01/21/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
01/21/2016	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
01/21/2016	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
01/21/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065489

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

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