Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050784
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZITHROMAX AZITHROMYCIN EQ 500MG BASE TABLET;ORAL Prescription AB Yes 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
05/24/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-784_Zithromax_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50784ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-784_Zithromax.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/30/2017 SUPPL-30 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/2017/050670s032,050710s046,050711s043,050784s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050670Orig1s032,050710Orig1s046,050711Orig1s043,050784Orig1s030ltr.pdf
02/10/2017 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050710s44-050711s41-050784s28lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050710Orig1s044,050711Orig1s041,050784Orig1s028ltr.pdf
05/23/2016 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050710s043,050711s040,050784s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050710Orig1s043,050711Orig1s040,050784Orig1s027ltr.pdf
02/19/2013 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050710s039,050711s036,050784s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050710s039,050711s036,050784s023ltr.pdf
06/06/2012 SUPPL-22 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
06/07/2014 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050710s037,050711s034,050784s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050710Orig1s037,050711Orig1s034,050784Orig11s021ltr.pdf
11/02/2012 SUPPL-19 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-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050710s033,050711s031,050784s018,.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050693s017,050710s033,050711s031,050730s026,050733s030,050784s018ltr.pdf
08/11/2010 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050710s032,050711s030,050784s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050710s032,050711s030,050784s017ltr.pdf
03/06/2009 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050710s028,050711s024,050784s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050710s028,050711s024,050784s012ltr.pdf
10/25/2007 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050710s023,050711s019,050784s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050710s023, 050711s019, 050784s007ltr.pdf
01/15/2004 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50784se1-004,slr006_zithromax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50784se1-004,slr006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050784_S004_S006_ZithromaxTOC.cfm
12/18/2003 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50711slr016,50710slr020,50784slr005ltr.pdf
01/15/2004 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50784se1-004,slr006_zithromax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50784se1-004,slr006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050784_S004_S006_ZithromaxTOC.cfm
10/16/2002 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50784slr002ltr.pdf
12/17/2002 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/30/2017 SUPPL-30 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/2017/050670s032,050710s046,050711s043,050784s030lbl.pdf
02/10/2017 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050710s44-050711s41-050784s28lbl.pdf
05/23/2016 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050710s043,050711s040,050784s027lbl.pdf
06/07/2014 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050710s037,050711s034,050784s021lbl.pdf
02/19/2013 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050710s039,050711s036,050784s023lbl.pdf
11/02/2012 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s019,050710s034,050711s032,050730s029,050784s019lbl.pdf
06/06/2012 SUPPL-22 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-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050710s033,050711s031,050784s018,.pdf
08/11/2010 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050710s032,050711s030,050784s017lbl.pdf
03/06/2009 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050710s028,050711s024,050784s012lbl.pdf
10/25/2007 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050710s023,050711s019,050784s007lbl.pdf
01/15/2004 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50784se1-004,slr006_zithromax_lbl.pdf
01/15/2004 SUPPL-4 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50784se1-004,slr006_zithromax_lbl.pdf
05/24/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-784_Zithromax_prntlbl.pdf

ZITHROMAX

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 207398 AUROBINDO PHARMA LTD
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET;ORAL Prescription No AB 210001 BIONPHARMA INC
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE TABLET;ORAL Prescription No AB 208249 CSPC OUYI
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 209044 SUNSHINE LAKE
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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