Clozapine

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1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

198 FDF Dossiers, 55 FDA Orange Book, 60 Europe, 12 Canada, 36 Australia, 9 South Africa, 26 Listed Dossiers

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TABLET, ORALLY DISINTEGRATING;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 5 Rochem International Inc, 19 SPI Pharma, 3 DKSH, 1 Pharm-RX Chemical, 6 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 15 BASF, 2 Corel Pharma Chem, 6 DFE Pharma, 6 Gangwal Chemicals, 2 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 28 Kerry, 13 Microlex e.U, 1 NEWEDGE Overseas, 1 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 28 Roquette, 1 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

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USFDA APPLICATION NUMBER - 203479 / DOSAGE - SUSPENSION;ORAL - 50MG/ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLOZAPINE(UNII: J60AR2IKIC) (CLOZAPINE - UNII:J60AR2IKIC)	CLOZAPINE	50mg in 1

Inactive Ingredients

Ingredient Name	Jazz Pharmaceuticals, Inc.
GLYCERIN(PDC6A3C0OX)
METHYLPARABEN SODIUM(CR6K9C2NHK)
POVIDONE, UNSPECIFIED(FZ989GH94E)
PROPYLPARABEN SODIUM(625NNB0G9N)
SODIUM HYDROXIDE(55X04QC32I)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE(5QWK665956)
SORBITOL(506T60A25R)
WATER(059QF0KO0R)
XANTHAN GUM(TTV12P4NEE)

Drug Product Composition: Clozapine

Clozapine

Clozapine

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

26 API Suppliers

15 USDMF

9 CEP/COS

1 JDMF

5 EU WC

3 KDMF

9 NDC API

15 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

198 FDF Dossiers

55 FDA Orange Book

60 Europe

12 Canada

36 Australia

9 South Africa

26 Listed Dossiers

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**

RELATED EXCIPIENT COMPANIES

1 Minakem

1 Evonik

5 Rochem International Inc

19 SPI Pharma

3 DKSH

1 Pharm-RX Chemical

6 Faran Shimi Pharmaceutical

6 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

14 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Pfanstiehl

3 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

15 BASF

2 Corel Pharma Chem

6 DFE Pharma

6 Gangwal Chemicals

2 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

28 Kerry

13 Microlex e.U

1 NEWEDGE Overseas

1 Novo Excipients

4 Pharmatrans-Sanaq

7 Pluviaendo

4 Prachin Chemical

28 Roquette

1 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

2 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

2 Ulanqab Kema New Material

1 Valens Pharmachem

3 Vasa Pharmachem

2 Zhejiang Huakang Pharmaceutical

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