Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065150
Company: TEVA
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
10/18/2017 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

10/18/2017 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

10/18/2017 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

03/20/2015 SUPPL-13 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/20/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

02/28/2013 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

12/18/2012 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

07/01/2011 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

12/13/2010 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

07/28/2010 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

11/30/2009 SUPPL-4 Labeling

Label is not available on this site.

02/12/2009 SUPPL-3 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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