Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065211
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZITHROMYCIN AZITHROMYCIN EQ 250MG 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-29 Labeling-Package Insert

Label is not available on this site.

05/14/2015 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/03/2014 SUPPL-24 Labeling-Container/Carton Labels

Label is not available on this site.

06/25/2013 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

10/09/2012 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.

07/01/2011 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

03/26/2010 SUPPL-12 Labeling

Label is not available on this site.

02/19/2009 SUPPL-11 Labeling

Label is not available on this site.

04/30/2008 SUPPL-8 Labeling

Label is not available on this site.

02/27/2008 SUPPL-1 Labeling

Label is not available on this site.

AZITHROMYCIN

TABLET;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZITHROMYCIN AZITHROMYCIN EQ 250MG BASE TABLET;ORAL Prescription No AB 065507 APOTEX CORP
AZITHROMYCIN AZITHROMYCIN EQ 250MG BASE TABLET;ORAL Prescription No AB 065398 LUPIN LTD
AZITHROMYCIN AZITHROMYCIN EQ 250MG BASE TABLET;ORAL Prescription No AB 065225 PLIVA
AZITHROMYCIN AZITHROMYCIN EQ 250MG BASE TABLET;ORAL Prescription No AB 065211 SANDOZ
AZITHROMYCIN AZITHROMYCIN EQ 250MG BASE TABLET;ORAL Prescription No AB 065153 TEVA
AZITHROMYCIN AZITHROMYCIN EQ 250MG BASE TABLET;ORAL Prescription No AB 065404 WOCKHARDT
ZITHROMAX AZITHROMYCIN EQ 250MG BASE TABLET;ORAL Prescription Yes AB 050711 PFIZER

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