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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050784
Company: PFIZER

Other Important Information from FDA

Products on NDA 050784

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050784

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
11/22/2021	SUPPL-37	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050670s036,050710s051,050784s037,050711s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050670Orig1s036;050710Orig1s051;050711Orig1s050;050784Orig1s037ltr.pdf
04/24/2019	SUPPL-34	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050710s049,050711s047,050784s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050710Orig1s049,050711Orig1s047,050784Orig1s034ltr.pdf
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.

Labels for NDA 050784

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2021	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050670s036,050710s051,050784s037,050711s050lbl.pdf
04/24/2019	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050710s049,050711s047,050784s034lbl.pdf
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

Therapeutic Equivalents for NDA 050784

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	215773	ACI
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	211792	ALEMBIC
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
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	065405	CHARTWELL RX
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
AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	065193	TEVA
ZITHROMAX	AZITHROMYCIN	EQ 500MG BASE	TABLET;ORAL	Prescription	Yes	AB	050784	PFIZER

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