Drugs@FDA: FDA Approved Drug Products

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

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

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