Application 021590

Type
NDA
Sponsor
JAZZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FAZACLO ODTCLOZAPINETABLET, ORALLY DISINTEGRATING;ORAL25MGYesNo
002FAZACLO ODTCLOZAPINETABLET, ORALLY DISINTEGRATING;ORAL100MGYesNo
003FAZACLO ODTCLOZAPINETABLET, ORALLY DISINTEGRATING;ORAL50MGNoNo
004FAZACLO ODTCLOZAPINETABLET, ORALLY DISINTEGRATING;ORAL12.5MGYesNo
005FAZACLO ODTCLOZAPINETABLET, ORALLY DISINTEGRATING;ORAL150MGYesNo
006FAZACLO ODTCLOZAPINETABLET, ORALLY DISINTEGRATING;ORAL200MGYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021590-001FAZACLO ODTCLOZAPINE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-10
N021590-002FAZACLO ODTCLOZAPINE100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-10
N021590-003FAZACLO ODTCLOZAPINE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-06-03
N021590-004FAZACLO ODTCLOZAPINE12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2007-05-30
N021590-005FAZACLO ODTCLOZAPINE150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-09
N021590-006FAZACLO ODTCLOZAPINE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-09

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021590-001FAZACLO ODT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-10caaa826d4ba7…
2026-08-18 06:07:402026-07N021590-002FAZACLO ODT100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-10caaa826d4ba7…
2026-08-18 06:07:402026-07N021590-003FAZACLO ODT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07N021590-004FAZACLO ODT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2007-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07N021590-005FAZACLO ODT150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07N021590-006FAZACLO ODT200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021590-001FAZACLO ODT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021590-002FAZACLO ODT100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021590-003FAZACLO ODT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021590-004FAZACLO ODT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2007-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021590-005FAZACLO ODT150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021590-006FAZACLO ODT200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021590-001FAZACLO ODT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021590-002FAZACLO ODT100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021590-003FAZACLO ODT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2005-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021590-004FAZACLO ODT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2007-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021590-005FAZACLO ODT150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021590-006FAZACLO ODT200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021590-001FAZACLO ODT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021590-002FAZACLO ODT100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021590-003FAZACLO ODT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORAL2005-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021590-004FAZACLO ODT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2007-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021590-005FAZACLO ODT150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021590-006FAZACLO ODT200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021590-001FAZACLO ODT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021590-002FAZACLO ODT100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021590-003FAZACLO ODT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORAL2005-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021590-004FAZACLO ODT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2007-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021590-005FAZACLO ODT150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021590-006FAZACLO ODT200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021590-001FAZACLO ODT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021590-002FAZACLO ODT100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021590-003FAZACLO ODT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORAL2005-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021590-004FAZACLO ODT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2007-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021590-005FAZACLO ODT150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021590-006FAZACLO ODT200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2010-07-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021590-001FAZACLO ODT25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021590-002FAZACLO ODT100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2004-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021590-003FAZACLO ODT50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORAL2005-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021590-004FAZACLO ODT12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2007-05-3003ed91905a0d…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N021590-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021590-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021590-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021590-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021590-006AB174a2ff9319b5…
2019-09-15 20:21 UTC2019-09N021590-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N021590-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N021590-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N021590-005AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N021590-006AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021590-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N021590-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N021590-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N021590-005AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N021590-006AB1ea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLOZAPINECLOZAPINENorthStar Rx LLC61fe53d5-ed5c-4e45-9189-709d08d386cb2026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOZAPINE
CLOZAPINECLOZAPINECardinal Health 107, LLC7c748f8a-73ce-4bd3-aa30-9c66657f06ec2026-04-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOZAPINE
ClozapineCLOZAPINEMylan Pharmaceuticals Inc.883b5d43-0339-7dc1-f775-93791fb9b9782026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOZAPINE
ClozapineCLOZAPINESafecor Health, LLC09231d80-6343-4a34-bd5b-100c547fd3c92026-03-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOZAPINE
ClozapineCLOZAPINESafecor Health LLC0fa59238-f0a6-4d00-9d8d-df2a43718fc12026-03-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOZAPINE
CLOZAPINECLOZAPINEMajor Pharmaceuticals9db7aefb-f607-4158-a310-181e631bc6482026-01-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOZAPINE
CLOZAPINECLOZAPINEAurobindo Pharma Limited5021d643-32d2-4167-b5d8-90870e68a7872025-12-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOZAPINE
ClozapineCLOZAPINEMylan Institutional Inc.d5c8a456-6f3c-4963-b321-4ed746f690e42025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOZAPINE
ClozapineCLOZAPINEAccord Healthcare Inc.25c0c6d5-f7b0-48e4-e054-00144ff8d46c2025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOZAPINE
ClozapineCLOZAPINEAmerican Health Packagingd36c298b-7292-46e0-898f-43d3e11c3cf42025-09-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOZAPINE
ClozapineCLOZAPINEMylan Pharmaceuticals Inc.9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b2192025-08-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOZAPINE
ClozapineCLOZAPINEMylan Institutional Inc.976be6e3-a9db-49c6-9b02-1ab168cf17b12025-07-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOZAPINE
ClozapineCLOZAPINETeva Pharmaceuticals USA, Inc.6fccf4f7-2e30-4272-9800-225aaef205842025-06-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOZAPINE
VERSACLOZCLOZAPINETruPharma LLC2592c9a8-fd74-4e0d-a895-b07b014cf3552025-06-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOZAPINE
ClozarilCLOZAPINEHLS Therapeutics (USA), Inc.90876802-0e3a-44c9-9ff7-1754dfbe736a2025-06-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOZAPINE
ClozapineCLOZAPINEAurobindo Pharma Limitedcaf2d4a6-2a23-4992-a807-560c4204afc42025-06-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLOZAPINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3010ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-3011ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-3012ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-3086ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-3086ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-3086ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-3086ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-3087ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-3087ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-3087ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-3087ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
18860-101FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-101FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-101FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-102FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-102FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-104FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-104FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-104FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-105FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-105FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-106FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-106FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62579SUPPL2020-04-15
62574SUPPL2020-04-15
57307SUPPL2019-01-22
47371SUPPL2017-03-02
47353SUPPL2017-02-27
37303SUPPL2015-10-22
28210SUPPL2015-10-02
37302SUPPL2015-09-16
37298SUPPL2015-09-16
28209SUPPL2015-09-16
28203SUPPL2015-09-16
24004ORIG2015-09-16
37301SUPPL2013-07-23
28207SUPPL2013-07-22
28208SUPPL2012-01-12
15843SUPPL2012-01-09
28206SUPPL2010-12-06
15842SUPPL2010-12-04
28205SUPPL2010-09-13
15841SUPPL2010-09-10
28204SUPPL2010-07-14
5812SUPPL2010-07-14
37300SUPPL2010-07-12
37299SUPPL2010-07-12
5811SUPPL2008-08-19
5810SUPPL2008-07-17
37297SUPPL2007-06-04
5809SUPPL2007-06-04
37296SUPPL2006-02-22
5808SUPPL2006-02-22
21751ORIG2005-10-06
28202SUPPL2005-08-16
15840SUPPL2005-08-15
5806SUPPL2005-08-15
37295SUPPL2005-06-10
5807SUPPL2005-06-10
28201SUPPL2004-09-07
28200SUPPL2004-06-23
15839ORIG2004-03-03
5805ORIG2004-02-27