Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065283
Company: SANDOZ

• Other Important Information from FDA

Products on ANDA 065283

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLARITHROMYCIN	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No
CLARITHROMYCIN	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065283

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/04/2007	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-25	Labeling-Package Insert		Label is not available on this site.
02/14/2023	SUPPL-22	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-16	Labeling-Package Insert		Label is not available on this site.
05/28/2015	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
05/28/2015	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
05/28/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/18/2013	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
12/22/2010	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
03/04/2009	SUPPL-6	Labeling		Label is not available on this site.
09/18/2008	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065283

CLARITHROMYCIN

FOR SUSPENSION;ORAL; 125MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLARITHROMYCIN	CLARITHROMYCIN	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065283	SANDOZ

FOR SUSPENSION;ORAL; 250MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLARITHROMYCIN	CLARITHROMYCIN	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065283	SANDOZ