FDA.reportPublic FDA data

Application 019777

Type
NDA
Sponsor
ALVOGEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZESTRILLISINOPRILTABLET;ORAL5MGYesNo
002ZESTRILLISINOPRILTABLET;ORAL10MGYesNo
003ZESTRILLISINOPRILTABLET;ORAL20MGYesNo
004ZESTRILLISINOPRILTABLET;ORAL40MGYesYes
005ZESTRILLISINOPRILTABLET;ORAL2.5MGYesNo
006ZESTRILLISINOPRILTABLET;ORAL30MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52427-438ZestrilLisinoprilAlmatica Pharma Inc.NDACurrent
52427-438ZestrilLisinoprilAlmatica Pharma Inc.NDACurrent
52427-438ZestrilLisinoprilAlmatica Pharma LLCNDACurrent
52427-438ZestrilLisinoprilAlmatica Pharma LLCNDACurrent
52427-438ZestrilLisinoprilAlmatica Pharma LLCNDACurrent
52427-439ZestrilLisinoprilAlmatica Pharma Inc.NDACurrent
52427-439ZestrilLisinoprilAlmatica Pharma Inc.NDACurrent
52427-439ZestrilLisinoprilAlmatica Pharma LLCNDACurrent
52427-439ZestrilLisinoprilAlmatica Pharma LLCNDACurrent
52427-439ZestrilLisinoprilAlmatica Pharma LLCNDACurrent
52427-440ZestrilLisinoprilAlmatica Pharma Inc.NDACurrent
52427-440ZestrilLisinoprilAlmatica Pharma Inc.NDACurrent
52427-440ZestrilLisinoprilAlmatica Pharma LLCNDACurrent
52427-440ZestrilLisinoprilAlmatica Pharma LLCNDACurrent
52427-440ZestrilLisinoprilAlmatica Pharma LLCNDACurrent
52427-441ZestrilLisinoprilAlmatica Pharma LLCNDACurrent
52427-441ZestrilLisinoprilAlmatica Pharma LLCNDACurrent
52427-441ZestrilLisinoprilAlmatica Pharma LLCNDACurrent
52427-441ZestrilLisinoprilAlmatica Pharma Inc.NDACurrent
52427-441ZestrilLisinoprilAlmatica Pharma Inc.NDACurrent
52427-442ZestrilLisinoprilAlmatica Pharma Inc.NDACurrent
52427-442ZestrilLisinoprilAlmatica Pharma Inc.NDACurrent
52427-442ZestrilLisinoprilAlmatica Pharma LLCNDACurrent
52427-442ZestrilLisinoprilAlmatica Pharma LLCNDACurrent
52427-442ZestrilLisinoprilAlmatica Pharma LLCNDACurrent
52427-443ZestrilLisinoprilAlmatica Pharma Inc.NDACurrent
52427-443ZestrilLisinoprilAlmatica Pharma Inc.NDACurrent
52427-443ZestrilLisinoprilAlmatica Pharma LLCNDACurrent
52427-443ZestrilLisinoprilAlmatica Pharma LLCNDACurrent
52427-443ZestrilLisinoprilAlmatica Pharma LLCNDACurrent
70518-1451ZestrilLisinoprilREMEDYREPACK INC.NDACurrent
70518-1451ZestrilLisinoprilREMEDYREPACK INC.NDACurrent
70518-1741ZestrilLisinoprilREMEDYREPACK INC.NDACurrent
70518-1741ZestrilLisinoprilREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49069SUPPL2017-07-25
49046SUPPL2017-07-25
33944SUPPL2016-04-29
1606SUPPL2016-04-22
19201SUPPL2015-08-27
11709SUPPL2015-08-26
11708SUPPL2015-01-09
19200SUPPL2014-12-30
33941SUPPL2014-06-30
1602SUPPL2014-06-27
11707SUPPL2013-11-21
19199SUPPL2013-11-07
19198SUPPL2012-11-05
11706SUPPL2012-11-02
1605SUPPL2012-08-16
33943SUPPL2012-08-15
11704SUPPL2012-05-07
1604SUPPL2012-05-04
19197SUPPL2012-04-02
11705SUPPL2012-03-29
33942SUPPL2011-08-12
1603SUPPL2011-08-09
19196SUPPL2010-01-07
11703SUPPL2009-11-19
1601SUPPL2009-05-26
11702SUPPL2009-05-25
1600SUPPL2007-10-10
1599SUPPL2007-07-24
19195SUPPL2006-06-20
23554ORIG2006-06-09
20346SUPPL2005-12-16
1598SUPPL2005-05-25
20348SUPPL2004-09-08
20347SUPPL2004-09-08
19193SUPPL2004-04-07
33940SUPPL2004-01-02
41019SUPPL2003-08-08
41018SUPPL2003-08-08
20343SUPPL2003-08-08
41017SUPPL2003-08-05
41016SUPPL2003-08-05
41015SUPPL2003-08-05
41014SUPPL2003-08-05
41013SUPPL2003-08-05
20342SUPPL2003-08-05
20340SUPPL2003-08-05
20339SUPPL2003-08-05
20338SUPPL2003-08-05
20336SUPPL2003-08-05
33939SUPPL2003-07-08
19194SUPPL2003-07-06
19192SUPPL2003-07-06
41012SUPPL2001-09-18
41011SUPPL2001-09-18
41010SUPPL2001-09-18
20341SUPPL2001-09-18
20337SUPPL2001-09-18
1597SUPPL2000-02-07
41021SUPPL1999-01-20
20345SUPPL1998-11-06
41020SUPPL1998-05-01
20344SUPPL1997-01-08