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Chemistry

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Also known as:
Molecular Formula
C18H19ClN4
Molecular Weight
326.8  g/mol
InChI Key
ZUXABONWMNSFBN-UHFFFAOYSA-N

Clozapine
1 2D Structure

Clozapine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
3-chloro-6-(4-methylpiperazin-1-yl)-5H-benzo[b][1,4]benzodiazepine
2.1.2 InChI
InChI=1S/C18H19ClN4/c1-22-8-10-23(11-9-22)18-14-4-2-3-5-15(14)20-16-7-6-13(19)12-17(16)21-18/h2-7,12,21H,8-11H2,1H3
2.1.3 InChI Key
ZUXABONWMNSFBN-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CN1CCN(CC1)C2=C3C=CC=CC3=NC4=C(N2)C=C(C=C4)Cl
2.1.5 Isomeric SMILES
CN1CCN(CC1)C2=C3C=CC=CC3=NC4=C(N2)C=C(C=C4)Cl
2.2 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 326.8 g/mol
Molecular Formula C18H19ClN4
XLogP33.2
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count4
Rotatable Bond Count1
Exact Mass326.1298243 g/mol
Monoisotopic Mass326.1298243 g/mol
Topological Polar Surface Area30.9 A^2
Heavy Atom Count23
Formal Charge0
Complexity584
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameClozapine
PubMed HealthClozapine (By mouth)
Drug ClassesAntipsychotic
Drug LabelVERSACLOZ, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine.The structural formula is: VERSACLOZ is available as a free-flowing yellow suspension. Each mL c...
Active IngredientClozapine
Dosage FormTablet
RouteOral
Strength200mg; 100mg; 25mg; 50mg; 12.5mg
Market StatusPrescription
CompanyIvax Sub Teva Pharms; Sun Pharm Inds; Mylan

2 of 6  
Drug NameClozaril
PubMed HealthClozapine (By mouth)
Drug ClassesAntipsychotic
Drug LabelCLOZARIL (clozapine), an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine.The structural formula isCLOZARIL is available in pale yellow tablets of 25mg...
Active IngredientClozapine
Dosage FormTablet
RouteOral
Strength100mg; 25mg
Market StatusPrescription
CompanyNovartis

3 of 6  
Drug NameFazaclo odt
Active IngredientClozapine
Dosage FormTablet, orally disintegrating
RouteOral
Strength200mg; 100mg; 25mg; 150mg; 12.5mg
Market StatusPrescription
CompanyJazz Pharms Iii

4 of 6  
Drug NameClozapine
PubMed HealthClozapine (By mouth)
Drug ClassesAntipsychotic
Drug LabelVERSACLOZ, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine.The structural formula is: VERSACLOZ is available as a free-flowing yellow suspension. Each mL c...
Active IngredientClozapine
Dosage FormTablet
RouteOral
Strength200mg; 100mg; 25mg; 50mg; 12.5mg
Market StatusPrescription
CompanyIvax Sub Teva Pharms; Sun Pharm Inds; Mylan

5 of 6  
Drug NameClozaril
PubMed HealthClozapine (By mouth)
Drug ClassesAntipsychotic
Drug LabelCLOZARIL (clozapine), an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine.The structural formula isCLOZARIL is available in pale yellow tablets of 25mg...
Active IngredientClozapine
Dosage FormTablet
RouteOral
Strength100mg; 25mg
Market StatusPrescription
CompanyNovartis

6 of 6  
Drug NameFazaclo odt
Active IngredientClozapine
Dosage FormTablet, orally disintegrating
RouteOral
Strength200mg; 100mg; 25mg; 150mg; 12.5mg
Market StatusPrescription
CompanyJazz Pharms Iii

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API Reference Price

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S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"450.00","actualQuantity":"450","unit":"KGS","unitRateFc":"275","totalValueFC":"124998.8","currency":"USD","unitRateINR":"23196.3","date":"16-Apr-2024","totalValueINR":"10438312.5","totalValueInUsd":"124998.8","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"3043918","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT, 6-808970 SANT JOAN DESPI , BARCELONA ,SPAINSDNF SPAIN","customerAddress":"ALEMBIC ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1714329000,"product":"CLOZAPINE (CAS NO:5786-21-0)","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"CAMBREX CORPORATION","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"1650.00","actualQuantity":"1650","unit":"KGS","unitRateFc":"389.9","totalValueFC":"650181.9","currency":"USD","unitRateINR":"32906","date":"29-Apr-2024","totalValueINR":"54294942","totalValueInUsd":"650181.9","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29335990","bill_no":"1001347","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717525800,"product":"CLOZAPINE IP","address":"ACME PLAZA , ANDHERI KURLA ROAD","city":"MUMBAI","supplier":"SINOBRIGHT PHARMACEUTICAL COMPANY LTD","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"825.00","actualQuantity":"825","unit":"KGS","unitRateFc":"80","totalValueFC":"66688.3","currency":"USD","unitRateINR":"6748","date":"05-Jun-2024","totalValueINR":"5567100","totalValueInUsd":"66688.3","indian_port":"JNPT","hs_no":"29335990","bill_no":"3831447","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"RM D 10\/F TOWER A BILLION CTR 1 WANG KWONG RD KLN BAY KL HONG KONGSDNF Hong Kong","customerAddress":"ACME PLAZA , ANDHERI KURLA ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718044200,"product":"CLOZAPINE (FOR PHARMACEUTICAL USE ONLY)","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"250.00","actualQuantity":"250","unit":"KGS","unitRateFc":"250","totalValueFC":"63114.4","currency":"USD","unitRateINR":"21075","date":"11-Jun-2024","totalValueINR":"5268750","totalValueInUsd":"63114.4","indian_port":"JNPT","hs_no":"29339990","bill_no":"3942748","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT, 6,08970 SANT JOAN DESPIBARCELONASDNF SPAIN","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720636200,"product":"CLOZAPINE IP","address":"ACME PLAZA , ANDHERI KURLA ROAD","city":"MUMBAI","supplier":"SINOBRIGHT PHARMACEUTICAL COMPANY LTD","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"850.00","actualQuantity":"850","unit":"KGS","unitRateFc":"80","totalValueFC":"68698.7","currency":"USD","unitRateINR":"6756","date":"11-Jul-2024","totalValueINR":"5742600","totalValueInUsd":"68698.7","indian_port":"JNPT","hs_no":"29335990","bill_no":"4439856","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"OFFICE F, 32\/F, PLAZA 88 NO. 88 YEUNG UK ROAD, TSUEN WAN, NT Hong Kong, , Hong Kong Hong Kong","customerAddress":"ACME PLAZA , ANDHERI KURLA ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720722600,"product":"CLOZAPINE (FOR PHARMACEUTICAL USE ONLY)","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"739.70","actualQuantity":"739.7","unit":"KGS","unitRateFc":"250","totalValueFC":"186825.2","currency":"USD","unitRateINR":"21112.5","date":"12-Jul-2024","totalValueINR":"15616916.25","totalValueInUsd":"186825.2","indian_port":"JNPT","hs_no":"29339990","bill_no":"4464887","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT, 6,08970 SANT JOAN DESPIBARCELONASDNF SPAIN","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722191400,"product":"CLOZAPINE IP\/BP\/USP","address":"102, MARINE CHAMBERS,","city":"MUMBAI, MAHARASHTRA.","supplier":"SINOBRIGHT PHARMACEUTICAL COMPANY LTD","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"BIO-PHARM","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"74","totalValueFC":"74848.9","currency":"USD","unitRateINR":"6256.7","date":"29-Jul-2024","totalValueINR":"6256700","totalValueInUsd":"74848.9","indian_port":"JNPT","hs_no":"29339990","bill_no":"4758847","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"OFFICE F, 32\/F, PLAZA 88 NO. 88 YEUNG UK ROAD, TSUEN WAN,NT,HONG KONG,CHINA HONG KONG","customerAddress":"102, MARINE CHAMBERS,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724437800,"product":"CLOZAPINE IP","address":"ACME PLAZA , ANDHERI KURLA ROAD","city":"MUMBAI","supplier":"SINOBRIGHT PHARMACEUTICAL COMPANY LTD","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"80","totalValueFC":"40463.3","currency":"USD","unitRateINR":"6788","date":"24-Aug-2024","totalValueINR":"3394000","totalValueInUsd":"40463.3","indian_port":"JNPT","hs_no":"29335990","bill_no":"5232321","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"OFFICE F, 32\/F, PLAZA 88 NO. 88 YEUNG UK ROAD, TSUEN WAN, NT Hong Kong, , Hong Kong Hong Kong","customerAddress":"ACME PLAZA , ANDHERI KURLA ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"CLOZAPINE BP 2024 (PHARMACEUTICAL RAW MATERIAL)","address":"TORRENT HOUSE,","city":"AHMEDABAD. GUJARAT","supplier":"M\/S. SUZHOU SOPHAR CO. LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"TORRENT PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"431.62","actualQuantity":"431.62","unit":"KGS","unitRateFc":"127.2","totalValueFC":"58059.3","currency":"USD","unitRateINR":"11272.5","date":"05-Sep-2024","totalValueINR":"4865436.45","totalValueInUsd":"58059.3","indian_port":"JNPT","hs_no":"29335990","bill_no":"5431368","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"HOUCHENG WENXING ROAD, JINGANG TOWN , ZHANGJIAGANG CITY, JIANGSU PROV., CHINA CHINA CHINA","customerAddress":"TORRENT HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725561000,"product":"CLOZAPINE USP","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"275","totalValueFC":"13930.3","currency":"USD","unitRateINR":"23347.5","date":"06-Sep-2024","totalValueINR":"1167375","totalValueInUsd":"13930.3","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"5468094","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT, 6-808970 SANT JO AN DESPI , BARCELONA ,SPAIN SDNF SPAIN SPAIN","customerAddress":"ALEMBIC ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726684200,"product":"CLOZAPINE USP","address":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"SINOBRIGHT PHARMACEUTICAL COMPANY LTD","supplierCountry":"CHINA","foreign_port":"SHENZHEN","customer":"APL HEALTHCARE","customerCountry":"INDIA","quantity":"84.00","actualQuantity":"84","unit":"KGS","unitRateFc":"175","totalValueFC":"14892.7","currency":"USD","unitRateINR":"14857.5","date":"19-Sep-2024","totalValueINR":"1248030","totalValueInUsd":"14892.7","indian_port":"APIIC MULTI PRODUCT SEZ NAIDUPET AP","hs_no":"29335990","bill_no":"5679633","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHENZHEN","supplierAddress":"OFFICE F, 32\/F PLAZA 88 NO 88 YEUNG UK ROAD TSUEN WAN,NT, HONG KONG SDNF China","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729189800,"product":"CLOZAPINE (FOR PHARMACEUTICAL USE ONLY)","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"400.00","actualQuantity":"400","unit":"KGS","unitRateFc":"250","totalValueFC":"101099","currency":"USD","unitRateINR":"21237.5","date":"18-Oct-2024","totalValueINR":"8495000","totalValueInUsd":"101099","indian_port":"JNPT","hs_no":"29339990","bill_no":"6193650","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT, 6,08970 SANT JOA N DESPIBARCELONA SDNF SPAIN","customerAddress":"564\/A\/22, ROAD NO.92"}]
02-Jan-2021
18-Oct-2024
KGS
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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FDA Orange Book

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01

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Medlab Asia & Asia Health
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

RLD : No

TE Code :

CLOZAPINE

Brand Name : CLOZAPINE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 2015-09-17

Application Number : 203807

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

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Medlab Asia & Asia Health
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

RLD : No

TE Code :

CLOZAPINE

Brand Name : CLOZAPINE

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Approval Date : 2015-09-17

Application Number : 203807

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Dr Reddy Company Banner

03

arrow
Medlab Asia & Asia Health
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

RLD : No

TE Code :

CLOZAPINE

Brand Name : CLOZAPINE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date : 2017-08-22

Application Number : 203807

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Dr Reddy Company Banner

04

arrow
Medlab Asia & Asia Health
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

RLD : No

TE Code :

CLOZAPINE

Brand Name : CLOZAPINE

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 2017-08-22

Application Number : 203807

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Dr Reddy Company Banner

05

ACCORD HLTHCARE

United Kingdom
Medlab Asia & Asia Health
Not Confirmed
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ACCORD HLTHCARE

United Kingdom
arrow
Medlab Asia & Asia Health
Not Confirmed

CLOZAPINE

Brand Name : CLOZAPINE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 2015-11-25

Application Number : 202873

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

Medlab Asia & Asia Health
Not Confirmed
arrow
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Medlab Asia & Asia Health
Not Confirmed

CLOZAPINE

Brand Name : CLOZAPINE

Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL

Dosage Strength : 100MG

Approval Date : 2015-11-25

Application Number : 90308

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

Medlab Asia & Asia Health
Not Confirmed
arrow
arrow
Medlab Asia & Asia Health
Not Confirmed

CLOZAPINE

Brand Name : CLOZAPINE

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Approval Date : 1997-11-26

Application Number : 74949

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

JAZZ

Ireland
Medlab Asia & Asia Health
Not Confirmed
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JAZZ

Ireland
arrow
Medlab Asia & Asia Health
Not Confirmed

CLOZAPINE

Brand Name : FAZACLO ODT

Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL

Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2004-02-10

Application Number : 21590

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

Medlab Asia & Asia Health
Not Confirmed
arrow
arrow
Medlab Asia & Asia Health
Not Confirmed

CLOZAPINE

Brand Name : CLOZAPINE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 2002-11-15

Application Number : 75713

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

MYLAN

U.S.A
Medlab Asia & Asia Health
Not Confirmed
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MYLAN

U.S.A
arrow
Medlab Asia & Asia Health
Not Confirmed

CLOZAPINE

Brand Name : CLOZAPINE

Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL

Dosage Strength : 200MG

Approval Date : 2023-08-07

Application Number : 201824

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 100MG

USFDA APPLICATION NUMBER - 19758

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DOSAGE - TABLET;ORAL - 200MG

USFDA APPLICATION NUMBER - 19758

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DOSAGE - TABLET;ORAL - 25MG

USFDA APPLICATION NUMBER - 19758

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DOSAGE - TABLET;ORAL - 50MG

USFDA APPLICATION NUMBER - 19758

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DOSAGE - SUSPENSION;ORAL - 50MG/ML

USFDA APPLICATION NUMBER - 203479

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

USFDA APPLICATION NUMBER - 21590

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

USFDA APPLICATION NUMBER - 21590

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

USFDA APPLICATION NUMBER - 21590

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

USFDA APPLICATION NUMBER - 21590

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

USFDA APPLICATION NUMBER - 21590

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