Clozapine Oral Tablet

Brand(s)
Clozaril
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2015-09-28)
Oldest Current Product
1989-09-30
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\CLOZAPINE
FDAOB
ORAL\TABLET\CLOZAPINE
SPL Active
ORAL\TABLET\CLOZAPINE
SPL Moiety
ORAL\TABLET\CLOZAPINE

product(s) by strength(s)

clozapine 100 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780127ClozarilNDANovartis Pharmaceuticals Corporation1989-09-30CLOZAPINEORALTABLETNDA0197585f0c6f5f-b906-4c8f-8580-3939a476a1c1

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937772ANDATeva Pharmaceuticals Usa Inc2009-09-18CLOZAPINEORALTABLETANDA07494947c4897c-ee95-4eaf-adbc-84130d021d2d
2003780860ANDAMylan Pharmaceuticals Inc.1999-07-08CLOZAPINEORALTABLETANDA075417883b5d43-0339-7dc1-f775-93791fb9b978
3510790922ANDAMylan Institutional Inc.1999-11-15CLOZAPINEORALTABLETANDA075417d5c8a456-6f3c-4963-b321-4ed746f690e4
4576640347ANDACaraco Pharmaceutical Laboratories, Ltd.2002-11-15CLOZAPINEORALTABLETANDA07571353bdb79c-c4cf-4818-b1f0-225e67a14536

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551543424ClozarilNDACardinal Health1989-09-30CLOZAPINEORALTABLET000780127NDA019758c43da258-73bb-4ca5-bfe8-1c8a0500f91d
2551548285ANDACardinal Health2010-02-12CLOZAPINEORALTABLET000937772ANDA07494977660c47-a2ad-4f1d-80d6-bdc315f04cbf

clozapine 200 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000934405ANDATeva Pharmaceuticals Usa Inc2007-05-15CLOZAPINEORALTABLETANDA07680947c4897c-ee95-4eaf-adbc-84130d021d2d
2003780973ANDAMylan Pharmaceuticals Inc.2010-04-20CLOZAPINEORALTABLETANDA075417883b5d43-0339-7dc1-f775-93791fb9b978
3510790749ANDAMylan Institutional Inc.2010-07-06CLOZAPINEORALTABLETANDA075417d5c8a456-6f3c-4963-b321-4ed746f690e4

clozapine 25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780126ClozarilNDANovartis Pharmaceuticals Corporation1989-09-30CLOZAPINEORALTABLETNDA0197585f0c6f5f-b906-4c8f-8580-3939a476a1c1

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000934359ANDATeva Pharmaceuticals Usa Inc2007-05-10CLOZAPINEORALTABLETANDA07494947c4897c-ee95-4eaf-adbc-84130d021d2d
2003780825ANDAMylan Pharmaceuticals Inc.1999-07-08CLOZAPINEORALTABLETANDA075417883b5d43-0339-7dc1-f775-93791fb9b978
3510790921ANDAMylan Institutional Inc.1999-11-15CLOZAPINEORALTABLETANDA075417d5c8a456-6f3c-4963-b321-4ed746f690e4
4576640345ANDACaraco Pharmaceutical Laboratories, Ltd.2002-11-15CLOZAPINEORALTABLETANDA07571353bdb79c-c4cf-4818-b1f0-225e67a14536

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1647251260ClozarilNDATya Pharmaceuticals1989-09-30CLOZAPINEORALTABLET000780126NDA0197580cf63b13-48b2-4b07-b241-617725b52f6b

clozapine 50 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000934404ANDATeva Pharmaceuticals Usa Inc2007-03-19CLOZAPINEORALTABLETANDA07680947c4897c-ee95-4eaf-adbc-84130d021d2d
2003780972ANDAMylan Pharmaceuticals Inc.2010-04-20CLOZAPINEORALTABLETANDA075417883b5d43-0339-7dc1-f775-93791fb9b978
3576640241ANDACaraco Pharmaceutical Laboratories, Ltd.2005-08-19CLOZAPINEORALTABLETANDA07571353bdb79c-c4cf-4818-b1f0-225e67a14536

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074546CLOZAPINETrueSANDOZ INC1996-08-30ANDA074546_001, ANDA074546_002
2ANDA074949CLOZAPINEIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1997-11-26ANDA074949_001, ANDA074949_002, ANDA074949_003, ANDA074949_004
3ANDA075162CLOZAPINETruePAR PHARMACEUTICAL2005-04-26ANDA075162_001, ANDA075162_002
4ANDA075417CLOZAPINEMYLAN PHARMACEUTICALS INC1999-05-27ANDA075417_001, ANDA075417_002, ANDA075417_003, ANDA075417_004, ANDA075417_005
5ANDA075713CLOZAPINESUN PHARMACEUTICAL INDUSTRIES INC2002-11-15ANDA075713_001, ANDA075713_002, ANDA075713_003
6ANDA076809CLOZAPINEIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA2005-12-16ANDA076809_001, ANDA076809_002, ANDA076809_003
7ANDA203807CLOZAPINEACTAVIS LABORATORIES FL INC2015-09-17ANDA203807_001, ANDA203807_002
8NDA019758CLOZARILHERITAGE LIFE SCIENCES BARBADOS INC1989-09-26NDA019758_001, NDA019758_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074546_001discontinuedCLOZAPINE (25MG)ORALTABLETFalse1996-08-30CLOZAPINE
2ANDA074546_002discontinuedCLOZAPINE (100MG)ORALTABLETFalse1996-08-30CLOZAPINE
3ANDA074949_001RXCLOZAPINE (25MG)ORALTABLETFalseAB1997-11-26CLOZAPINE
4ANDA074949_002RXCLOZAPINE (100MG)ORALTABLETFalseAB1997-11-26CLOZAPINE
5ANDA074949_003RXCLOZAPINE (12.5MG)ORALTABLETFalseAB2003-07-31CLOZAPINE
6ANDA074949_004RXCLOZAPINE (50MG)ORALTABLETFalseAB2005-04-25CLOZAPINE
7ANDA075162_001discontinuedCLOZAPINE (25MG)ORALTABLETFalse2005-04-26CLOZAPINE
8ANDA075162_002discontinuedCLOZAPINE (100MG)ORALTABLETFalse2005-04-26CLOZAPINE
9ANDA075417_001RXCLOZAPINE (25MG)ORALTABLETFalseAB1999-05-27CLOZAPINE
10ANDA075417_002RXCLOZAPINE (100MG)ORALTABLETFalseAB1999-05-27CLOZAPINE
11ANDA075417_003RXCLOZAPINE (12.5MG)ORALTABLETFalseAB2010-04-15CLOZAPINE
12ANDA075417_004RXCLOZAPINE (50MG)ORALTABLETFalseAB2010-04-15CLOZAPINE
13ANDA075417_005RXCLOZAPINE (200MG)ORALTABLETFalseAB2010-04-15CLOZAPINE
14ANDA075713_001RXCLOZAPINE (25MG)ORALTABLETFalseAB2002-11-15CLOZAPINE
15ANDA075713_002RXCLOZAPINE (100MG)ORALTABLETFalseAB2002-11-15CLOZAPINE
16ANDA075713_003RXCLOZAPINE (50MG)ORALTABLETFalseAB2005-08-19CLOZAPINE
17ANDA076809_001RXCLOZAPINE (200MG)ORALTABLETFalseAB2005-12-16CLOZAPINE
18ANDA076809_002RXCLOZAPINE (100MG)ORALTABLETFalseAB2005-12-16CLOZAPINE
19ANDA076809_003RXCLOZAPINE (50MG)ORALTABLETFalseAB2005-12-16CLOZAPINE
20ANDA203807_001RXCLOZAPINE (25MG)ORALTABLETFalseAB2015-09-17CLOZAPINE
21ANDA203807_002RXCLOZAPINE (100MG)ORALTABLETFalseAB2015-09-17CLOZAPINE
22NDA019758_001RXCLOZAPINE (25MG)ORALTABLETFalseAB1989-09-26CLOZARIL
23NDA019758_002RXCLOZAPINE (100MG)ORALTABLETTrueAB1989-09-26CLOZARIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10cf63b13-48b2-4b07-b241-617725b52f6b (view SPL)These highlights do not include all the information needed to use CLOZARIL safely and effectively. See full prescribing information for CLOZARIL. CLOZARIL (clozapine) tablets, for oral use Initial U.S. Approval: 1989prescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2013-11-132647251260
247c4897c-ee95-4eaf-adbc-84130d021d2d (view SPL)These highlights do not include all the information needed to use CLOZAPINE TABLETS USP safely and effectively. See full prescribing information for CLOZAPINE TABLETS USP. CLOZAPINE tablets, for oral use Initial U.S. Approval: 1989prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-11-2420000934359, 000934404, 000934405, 000937772
353bdb79c-c4cf-4818-b1f0-225e67a14536 (view SPL)These highlights do not include all the information needed to use clozapine tablets USP safely and effectively. See full prescribing information for clozapine tablets.CLOZAPINE tablets USP, for oral useInitial U.S. Approval: 1989prescriptionHuman PrescriptionCaraco Pharmaceutical Laboratories, Ltd.MANUFACTURE2015-10-1314576640241, 576640345, 576640347
45f0c6f5f-b906-4c8f-8580-3939a476a1c1 (view SPL)These highlights do not include all the information needed to use CLOZARIL safely and effectively. See full prescribing information for CLOZARIL. CLOZARIL (clozapine) tablets, for oral use Initial U.S. Approval: 1989prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-09-2822000780126, 000780127
577660c47-a2ad-4f1d-80d6-bdc315f04cbf (view SPL)These highlights do not include all the information needed to use Clozapine Tablets USP safely and effectively. See full prescribing information for Clozapine Tablets USP. Clozapine Tablets USP, For Oral Use Initial U.S. Approval: 1989prescriptionHuman PrescriptionCardinal HealthREPACK2014-06-124551548285
6883b5d43-0339-7dc1-f775-93791fb9b978 (view SPL)These highlights do not include all the information needed to use CLOZAPINE TABLETS USP safely and effectively. See full prescribing information for CLOZAPINE TABLETS USP. CLOZAPINE tablets, for oral use Initial U.S. Approval: 1989prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-10-2913003780825, 003780860, 003780972, 003780973
7c43da258-73bb-4ca5-bfe8-1c8a0500f91d (view SPL)ClozarilprescriptionHuman PrescriptionCardinal HealthREPACK2012-11-092551543424
8d5c8a456-6f3c-4963-b321-4ed746f690e4 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2014-01-034510790749, 510790921, 510790922

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII