Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065212
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZITHROMYCIN AZITHROMYCIN EQ 500MG 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
11/12/2016 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

01/05/2017 SUPPL-25 Labeling-Container/Carton Labels

Label is not available on this site.

05/14/2015 SUPPL-23 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/03/2014 SUPPL-22 Labeling-Container/Carton Labels

Label is not available on this site.

06/25/2013 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

10/09/2012 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

10/09/2012 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

07/05/2011 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

03/26/2010 SUPPL-10 Labeling

Label is not available on this site.

02/19/2009 SUPPL-9 Labeling

Label is not available on this site.

04/30/2008 SUPPL-6 Labeling

Label is not available on this site.

05/08/2006 SUPPL-1 Labeling

Label is not available on this site.

AZITHROMYCIN

TABLET;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET;ORAL Prescription No AB 065509 APOTEX CORP
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET;ORAL Prescription No AB 065399 LUPIN LTD
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET;ORAL Prescription No AB 065223 PLIVA
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET;ORAL Prescription No AB 065212 SANDOZ
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET;ORAL Prescription No AB 065193 TEVA
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET;ORAL Prescription No AB 065405 WOCKHARDT
ZITHROMAX AZITHROMYCIN EQ 500MG BASE TABLET;ORAL Prescription Yes AB 050784 PFIZER

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