FDA.reportPublic FDA data

Application 019758

Type
NDA
Sponsor
HERITAGE LIFE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOZARILCLOZAPINETABLET;ORAL25MGYesNo
002CLOZARILCLOZAPINETABLET;ORAL100MGYesYes
003CLOZARILCLOZAPINETABLET;ORAL50MGYesNo
004CLOZARILCLOZAPINETABLET;ORAL200MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-5989ClozapineclozapineSandoz Inc.NDACurrent
0781-5989ClozapineclozapineSandoz Inc.NDACurrent
0781-5989ClozapineclozapineSandoz Inc.NDACurrent
0781-5989ClozapineclozapineSandoz Inc.NDACurrent
0781-5992ClozapineclozapineSandoz Inc.NDACurrent
0781-5992ClozapineclozapineSandoz Inc.NDACurrent
0781-5992ClozapineclozapineSandoz Inc.NDACurrent
0781-5992ClozapineclozapineSandoz Inc.NDACurrent
64725-1260ClozarilclozapineTYA PharmaceuticalsNDACurrent
69809-0126ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0126ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0126ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0126ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0126ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0126ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0126ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0127ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0127ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0127ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0127ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0127ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0127ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0127ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0130ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0130ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0130ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0130ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0130ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0135ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0135ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0135ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0135ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
69809-0135ClozarilclozapineHLS Therapeutics (USA), Inc.NDACurrent
72721-1725ClozapineclozapineHeartwood PharmaNDACurrent
72721-1725ClozapineclozapineHeartwood PharmaNDACurrent
72721-1725ClozapineclozapineHeartwood PharmaNDACurrent
72721-1725ClozapineclozapineHeartwood PharmaNDACurrent
72721-1750ClozapineclozapineHeartwood PharmaNDACurrent
72721-1750ClozapineclozapineHeartwood PharmaNDACurrent
72721-1750ClozapineclozapineHeartwood PharmaNDACurrent
72721-1760ClozapineclozapineHeartwood PharmaNDACurrent
72721-1760ClozapineclozapineHeartwood PharmaNDACurrent
72721-1760ClozapineclozapineHeartwood PharmaNDACurrent
72721-1760ClozapineclozapineHeartwood PharmaNDACurrent
72721-1770ClozapineclozapineHeartwood PharmaNDACurrent
72721-1770ClozapineclozapineHeartwood PharmaNDACurrent
72721-1770ClozapineclozapineHeartwood PharmaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82579SUPPL 2026-05-04
82582SUPPL 2025-06-16
82580SUPPL 2025-06-16
81151SUPPL 2025-02-07
80926SUPPL 2025-02-04
80850SUPPL 2025-01-15
80849SUPPL 2025-01-15
80848SUPPL 2025-01-15
79603SUPPL 2024-09-16
79587SUPPL 2024-09-16
75935SUPPL 2023-10-25
75634SUPPL 2023-10-02
75633SUPPL 2023-10-02
74408SUPPL 2023-05-31
72983SUPPL2022-12-21
72973SUPPL2022-12-21
69407SUPPL2021-11-24
69298SUPPL2021-11-12
68255SUPPL2021-08-02
66304SUPPL2021-02-22
66224SUPPL2021-02-16
66213SUPPL2021-02-16
62571SUPPL2020-04-15
62569SUPPL2020-04-15
57312SUPPL2019-01-22
47390SUPPL2017-03-02
47351SUPPL2017-02-27
47017SUPPL2017-01-30
46997SUPPL2017-01-26
46486SUPPL2016-12-22
46496SUPPL2016-12-21
33913SUPPL2015-10-22
19153SUPPL2015-10-13
33912SUPPL2015-09-23
1574SUPPL2015-09-22
44445ORIG2015-09-16
19152SUPPL2015-09-16
19145SUPPL2015-09-16
11677SUPPL2015-09-16
11672SUPPL2015-09-16
11676SUPPL2015-01-09
1573SUPPL2014-12-23
1572SUPPL2014-10-01
33911SUPPL2014-09-30
33910SUPPL2013-07-23
33908SUPPL2013-07-23
19150SUPPL2013-07-22
33909SUPPL2013-03-26
33907SUPPL2013-03-26
11675SUPPL2013-03-26
19151SUPPL2013-03-25
19149SUPPL2013-03-25
1571SUPPL2013-03-25
20314SUPPL2012-03-14
23553ORIG2011-12-22
11674SUPPL2011-10-25
19147SUPPL2011-10-24
19148SUPPL2010-12-06
33906SUPPL2010-12-04
19146SUPPL2010-01-26
11673SUPPL2010-01-20
19142SUPPL2008-11-06
1570SUPPL2008-08-19
19144SUPPL2008-07-01
20313SUPPL2008-02-19
19143SUPPL2005-12-13
11671SUPPL2005-06-29
1569SUPPL2005-06-29
11670SUPPL2005-05-17
1568SUPPL2005-05-17
1566SUPPL2004-06-01
1567SUPPL2003-12-24
11669SUPPL2003-06-16
33905SUPPL2003-04-04
19141SUPPL2002-07-05
33904SUPPL2002-01-14
19140SUPPL2002-01-14