Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050730
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZITHROMAX AZITHROMYCIN EQ 600MG BASE TABLET;ORAL Prescription AB Yes 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
06/12/1996 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/24/2019 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050693s031,050730s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050693Orig1s031,050730Orig1s041ltr.pdf
03/29/2017 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050693s029,050730s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050693Orig1s029,050730Orig1s037ltr.pdf
02/10/2017 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050693s27-050730s35lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050693Orig1s027,050730Orig1s035ltr.pdf
05/23/2016 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050693s026,050730s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050693Orig1s026,050730Orig1s034ltr.pdf
02/19/2013 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050693s023,050730s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050693Orig1s023,050730Orig1s031ltr.pdf
06/06/2012 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022ltr.pdf
06/06/2014 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050693s021,050730s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050693Orig1s021,050730Orig1s029ltr.pdf
11/02/2012 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s019,050710s034,050711s032,050730s029,050784s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693Orig1s019,050710Oirg1s034,050711Orig1s032,050730Orig1s027,050784Orig1s019ltr.pdf
01/28/2011 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050693s017,050730s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050693s017,050710s033,050711s031,050730s026,050733s030,050784s018ltr.pdf
08/11/2010 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050693s015,050730s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050693s015,050730s025ltr.pdf
03/06/2009 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050730s021,050693s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050693s014,050730s021ltr.pdf
10/25/2007 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050670s024,050693s010,050730s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050670s024, 050693s010, 050730s014ltr.pdf
01/15/2004 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr022,50693slr009,50730slr012ltr.pdf
03/24/2004 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50670slr021,50693slr008,50730slr011_zithromax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr021,50693slr008,50730slr011ltr.pdf
07/22/2002 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf
12/04/2001 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/16/2002 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr017,50693slr005,50730slr007ltr.pdf
11/13/2000 SUPPL-5 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax.cfm
11/11/2000 SUPPL-4 Labeling

Label is not available on this site.

01/20/2000 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/19/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/12/1997 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/24/2019 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050693s031,050730s041lbl.pdf
03/29/2017 SUPPL-37 Labeling Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050693s029,050730s037lbl.pdf
02/10/2017 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050693s27-050730s35lbl.pdf
05/23/2016 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050693s026,050730s034lbl.pdf
06/06/2014 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050693s021,050730s029lbl.pdf
02/19/2013 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050693s023,050730s031lbl.pdf
11/02/2012 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s019,050710s034,050711s032,050730s029,050784s019lbl.pdf
06/06/2012 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022lbl.pdf
01/28/2011 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050693s017,050730s026lbl.pdf
08/11/2010 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050693s015,050730s025lbl.pdf
03/06/2009 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050730s021,050693s014lbl.pdf
10/25/2007 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050670s024,050693s010,050730s014lbl.pdf
03/24/2004 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50670slr021,50693slr008,50730slr011_zithromax_lbl.pdf
11/13/2000 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_prntlbl.pdf

ZITHROMAX

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 209999 BIONPHARMA INC
AZITHROMYCIN AZITHROMYCIN EQ 600MG BASE TABLET;ORAL Prescription No AB 207566 CSPC OUYI
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 209043 SUNSHINE LAKE
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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