Application 050784

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZITHROMAX	AZITHROMYCIN	TABLET;ORAL	EQ 500MG BASE	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-3070	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3070	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3070	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3070	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3070	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3070	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3070	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3070	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3070	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3070	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3070	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
35356-798	azithromycin	azithromycin	Lake Erie Medical DBA Quality Care Products LLC	NDA AUTHORIZED GENERIC	Current
59762-3070	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3070	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3070	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3070	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3070	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3070	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3070	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3070	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
63629-6764	azithromycin	azithromycin	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-6764	azithromycin	azithromycin	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
70518-0336	Zithromax	azithromycin dihydrate	REMEDYREPACK INC.	NDA	Current
70518-0336	Zithromax	azithromycin dihydrate	REMEDYREPACK INC.	NDA	Current
70518-0336	Zithromax	azithromycin dihydrate	REMEDYREPACK INC.	NDA	Current
70518-0336	Zithromax	azithromycin dihydrate	REMEDYREPACK INC.	NDA	Current
70518-0336	Zithromax	azithromycin dihydrate	REMEDYREPACK INC.	NDA	Current
70518-0336	Zithromax	azithromycin dihydrate	REMEDYREPACK INC.	NDA	Current
70518-0336	Zithromax	azithromycin dihydrate	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70172	SUPPL	2022-02-15
69373	SUPPL	2021-11-22
58420	SUPPL	2019-04-25
58397	SUPPL	2019-04-24
47833	SUPPL	2017-04-03
47796	SUPPL	2017-03-31
47190	SUPPL	2017-02-13
47174	SUPPL	2017-02-13
39332	SUPPL	2016-05-25
30537	SUPPL	2016-05-25
30535	SUPPL	2014-06-11
18240	SUPPL	2014-06-10
44208	ORIG	2013-03-12
39331	SUPPL	2013-02-21
30536	SUPPL	2013-02-21
30534	SUPPL	2012-11-06
18239	SUPPL	2012-11-06
18241	SUPPL	2012-06-11
8283	SUPPL	2012-06-08
18238	SUPPL	2011-02-04
8282	SUPPL	2011-02-03
18237	SUPPL	2010-08-19
30533	SUPPL	2010-08-17
18236	SUPPL	2009-04-03
30532	SUPPL	2009-03-03
8281	SUPPL	2007-11-08
39330	SUPPL	2007-11-07
42736	SUPPL	2007-06-11
42735	SUPPL	2007-06-11
39329	SUPPL	2004-01-22
39328	SUPPL	2004-01-22
30531	SUPPL	2004-01-22
30530	SUPPL	2004-01-22
8280	SUPPL	2003-12-22
8279	SUPPL	2002-10-16
42734	ORIG	2002-05-24
39327	ORIG	2002-05-24
8278	ORIG	2002-05-24

Application 050784

Related Records#

Application Products#

NDC Listings For This Application#

Documents#