Application 050710

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZITHROMAX	AZITHROMYCIN	FOR SUSPENSION;ORAL	EQ 100MG BASE/5ML	Yes	No
002	ZITHROMAX	AZITHROMYCIN	FOR SUSPENSION;ORAL	EQ 200MG BASE/5ML	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
35356-044	azithromycin	azithromycin	Lake Erie Medical DBA Quality Care Products LLC	NDA AUTHORIZED GENERIC	Current
50090-2491	azithromycin	azithromycin	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-2491	azithromycin	azithromycin	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-2491	azithromycin	azithromycin	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-2509	azithromycin	azithromycin	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-2509	azithromycin	azithromycin	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-2509	azithromycin	azithromycin	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
55695-029	azithromycin	azithromycin	Department of State Health Services, Pharmacy Branch	NDA AUTHORIZED GENERIC	Current
55700-211	azithromycin	azithromycin	Lake Erie Medical DBA Quality Care Products LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3130	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3130	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3130	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69371	SUPPL	2021-11-22
58418	SUPPL	2019-04-25
58395	SUPPL	2019-04-24
47835	SUPPL	2017-04-03
47798	SUPPL	2017-03-31
47188	SUPPL	2017-02-13
47172	SUPPL	2017-02-13
18075	SUPPL	2016-05-25
8069	SUPPL	2016-05-25
30327	SUPPL	2014-06-11
18072	SUPPL	2014-06-10
23722	ORIG	2013-03-12
30329	SUPPL	2013-02-21
18074	SUPPL	2013-02-21
39158	SUPPL	2012-11-06
30326	SUPPL	2012-11-06
18073	SUPPL	2012-06-11
30328	SUPPL	2012-06-08
18071	SUPPL	2011-02-04
8068	SUPPL	2011-02-03
18070	SUPPL	2010-08-19
30325	SUPPL	2010-08-17
39157	SUPPL	2009-04-03
30324	SUPPL	2009-03-03
30323	SUPPL	2007-11-08
18069	SUPPL	2007-11-07
22193	SUPPL	2004-06-04
30321	SUPPL	2004-04-29
39156	SUPPL	2004-01-22
30322	SUPPL	2004-01-22
18068	SUPPL	2004-01-22
8066	SUPPL	2004-01-22
8067	SUPPL	2003-12-22
30320	SUPPL	2003-07-06
8063	SUPPL	2002-10-16
8065	SUPPL	2002-07-22
39155	SUPPL	2002-05-24
30319	SUPPL	2002-05-24
39154	SUPPL	2001-12-14
39153	SUPPL	2001-12-14
30318	SUPPL	2001-12-14
8064	SUPPL	2001-12-14

Application 050710

Related Records#

Application Products#

NDC Listings For This Application#

Documents#