Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065209
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/14/2005 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
01/05/2017 SUPPL-23 Labeling-Container/Carton Labels

Label is not available on this site.

05/14/2015 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

06/25/2013 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

10/09/2012 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

03/12/2012 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

07/01/2011 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

08/19/2010 SUPPL-10 Labeling-Patient Package Insert

Label is not available on this site.

06/30/2008 SUPPL-7 Labeling

Label is not available on this site.

01/29/2008 SUPPL-6 Labeling

Label is not available on this site.

06/20/2007 SUPPL-4 Labeling

Label is not available on this site.

AZITHROMYCIN

TABLET;ORAL; EQ 600MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET;ORAL Prescription No AB 065508 APOTEX CORP
AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET;ORAL Prescription No AB 065400 LUPIN LTD
AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET;ORAL Prescription No AB 065360 MYLAN
AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET;ORAL Prescription No AB 065218 PLIVA
AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET;ORAL Prescription No AB 065209 SANDOZ
AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET;ORAL Prescription No AB 065150 TEVA
AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET;ORAL Prescription No AB 065302 WOCKHARDT
ZITHROMAX AZITHROMYCIN EQ 600MG BASE TABLET;ORAL Prescription Yes AB 050730 PFIZER

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