8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine

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ACTIVE PHARMA INGREDIENTS

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DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG, TABLET;ORAL - 200MG, TABLET;ORAL - 25MG, TABLET;ORAL - 50MG, SUSPENSION;ORAL - 50MG/ML, TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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2 EUROAPI, 1 Minakem, 5 Evonik, 5 Rochem International Inc, 20 SPI Pharma, 3 DKSH, 1 Pharm-RX Chemical, 6 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 3 Kirsch Pharma, 3 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 15 BASF, 2 CD Formulation, 2 Corel Pharma Chem, 6 DFE Pharma, 6 Gangwal Chemicals, 2 Ideal Cures, 4 Ingredion Pharma Solutions, 16 Kerry, 2 Keval Exports, 13 Microlex e.U, 3 Nitika Pharmaceutical Specialities, 1 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 3 Prachin Chemical, 28 Roquette, 1 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

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PATENTS & EXCLUSIVITIES

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REF. STANDARDS & IMPURITIES

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ANALYTICAL

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USFDA APPLICATION NUMBER - 19758 / DOSAGE - TABLET;ORAL - 200MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLOZAPINE(UNII: J60AR2IKIC) (CLOZAPINE - UNII:J60AR2IKIC)	CLOZAPINE	100mg

Inactive Ingredients

Ingredient Name	Teva Pharmaceuticals USA, Inc.	Mylan Institutional Inc.	Mylan Pharmaceuticals Inc.	Aurobindo Pharma Limited	Cardinal Health	Novartis Pharmaceuticals Corporation	Actavis Pharma, Inc.	American Health Packaging	Avera McKennan Hospital	Golden State Medical Supply, Inc.	Heartwood Pharma	Mayne Pharma	Sandoz Inc.	Sun Pharmaceutical Industries, Inc.
ANHYDROUS LACTOSE(3SY5LH9PMK)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
CROSPOVIDONE(2S7830E561)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C RED NO. 40(WZB9127XOA)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LACTOSE(J2B2A4N98G)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POVIDONE K30(U725QWY32X)
POVIDONE K90(RDH86HJV5Z)
POVIDONE(FZ989GH94E)
Povidone, Unspecified(FZ989GH94E)
POVIDONES(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)

Setid C43da258 73bb 4ca5 Bfe8 1c8a0500f91d Applno 19758 Form Tablet Oral Dosage 200mg - Drug Product Composition: 8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine