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Also known as: 100286-90-6, Irinotecan hcl, Topotecin, Campto, Camptothecin 11 hydrochloride, Camptosar
Molecular Formula
C33H39ClN4O6
Molecular Weight
623.1  g/mol
InChI Key
GURKHSYORGJETM-WAQYZQTGSA-N
FDA UNII
06X131E4OE

Irinotecan Hydrochloride
A semisynthetic camptothecin derivative that inhibits DNA TOPOISOMERASE I to prevent nucleic acid synthesis during S PHASE. It is used as an antineoplastic agent for the treatment of COLORECTAL NEOPLASMS and PANCREATIC NEOPLASMS.
1 2D Structure

Irinotecan Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(19S)-10,19-diethyl-19-hydroxy-14,18-dioxo-17-oxa-3,13-diazapentacyclo[11.8.0.02,11.04,9.015,20]henicosa-1(21),2,4(9),5,7,10,15(20)-heptaen-7-yl] 4-piperidin-1-ylpiperidine-1-carboxylate;hydrochloride
2.1.2 InChI
InChI=1S/C33H38N4O6.ClH/c1-3-22-23-16-21(43-32(40)36-14-10-20(11-15-36)35-12-6-5-7-13-35)8-9-27(23)34-29-24(22)18-37-28(29)17-26-25(30(37)38)19-42-31(39)33(26,41)4-2;/h8-9,16-17,20,41H,3-7,10-15,18-19H2,1-2H3;1H/t33-;/m0./s1
2.1.3 InChI Key
GURKHSYORGJETM-WAQYZQTGSA-N
2.1.4 Canonical SMILES
CCC1=C2CN3C(=CC4=C(C3=O)COC(=O)C4(CC)O)C2=NC5=C1C=C(C=C5)OC(=O)N6CCC(CC6)N7CCCCC7.Cl
2.1.5 Isomeric SMILES
CCC1=C2CN3C(=CC4=C(C3=O)COC(=O)[C@@]4(CC)O)C2=NC5=C1C=C(C=C5)OC(=O)N6CCC(CC6)N7CCCCC7.Cl
2.2 Other Identifiers
2.2.1 UNII
06X131E4OE
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 7 Ethyl 10 Hydroxycamptothecin

2. 7-ethyl-10-hydroxycamptothecin

3. Camptosar

4. Camptothecin 11

5. Camptothecin-11

6. Cpt 11

7. Cpt-11

8. Cpt11

9. Irinotecan

10. Irrinotecan

11. Nk012 Compound

12. Sn 38

13. Sn 38 11

14. Sn-38

15. Sn-38-11

16. Sn3811

2.3.2 Depositor-Supplied Synonyms

1. 100286-90-6

2. Irinotecan Hcl

3. Topotecin

4. Campto

5. Camptothecin 11 Hydrochloride

6. Camptosar

7. Cpt 11

8. Cpt-11

9. Irinotecan (hydrochloride)

10. Camptothecin 11

11. U 101440e

12. Chebi:5971

13. (s)-4,11-diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl [1,4'-bipiperidine]-1'-carboxylate Hydrochloride

14. Camptothecin Analog

15. 06x131e4oe

16. 7-ethyl-10-(4-(1-piperidino)-1-piperidino)carbonyloxy Camptothecin Hydrochloride

17. Nsc616348

18. Nsc-616348

19. Ncgc00095190-01

20. Dsstox_cid_25953

21. Dsstox_rid_81249

22. Dsstox_gsid_45953

23. [(19s)-10,19-diethyl-19-hydroxy-14,18-dioxo-17-oxa-3,13-diazapentacyclo[11.8.0.02,11.04,9.015,20]henicosa-1(21),2,4(9),5,7,10,15(20)-heptaen-7-yl] 4-piperidin-1-ylpiperidine-1-carboxylate;hydrochloride

24. Irinotecan Hydrochloride Anhydrous

25. Cas-100286-90-6

26. U-101440e

27. Unii-06x131e4oe

28. Irinotecan Hydrochloride [usan:jan]

29. Mfcd01862255

30. Irinotecanhydrochloride

31. Cpt-11 Hydrochloride

32. Irinotecan Monohydrochloride

33. Schembl4033

34. Camptosar (tn) (pharmacia)

35. (s)-[1,4'-bipiperidine]-1'-carboxylic Acid, 4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl Ester Hydrochloride

36. Spectrum1505821

37. Chembl541887

38. Dtxsid6045953

39. Hms1922j04

40. Pharmakon1600-01505821

41. Amy24895

42. Bcp17234

43. Irinotecan Hydrochloride (anhydrous)

44. Tox21_111479

45. Hy-16562a

46. Nsc759878

47. S5026

48. Akos015901921

49. Tox21_111479_1

50. Ccg-213561

51. Irinotecan Hydrochloride [who-dd]

52. Ncgc00095190-02

53. Ncgc00178697-04

54. (1,4'-bipiperidine)-1'-carboxylic Acid, (4s)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1h-pyrano(3',4':6,7)indolizino(1,2-b)quinolin-9-yl Ester, Monohydrochloride

55. (1,4'-bipiperidine)-1'-carboxylic Acid, 3,4,12,14-tetrahydro-4,11-diethyl-4-hydroxy-3,4-dioxo-1h-pyrano(3',4':6,7)indolizino(1,2-b)quinolin-9-yl Ester, Monohydrochloride, (s)-

56. Ac-28335

57. As-13304

58. I0714

59. Irinotecan Hydrochloride Anhydrous [mi]

60. Irinotecan Hydrochloride, Topoisomerase Inhibitor

61. 286i906

62. A897508

63. Sr-01000763864

64. Q-100016

65. Sr-01000763864-3

66. Q27106952

67. Z1550648758

68. (+)-7-ethyl-10-hydroxycamptothecine 10-(1,4'-bipiperidine)-1'-carboxylate, Monohydrochloride

69. (1,4'-bipiperidine)-1'-carboxylic Acid, (4s)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1h-pyrano(3',4':6,7)indolizino(1,2-b)quinolin-9-yl Ester, Hydrochloride (1:1)

70. (19s)-10,19-diethyl-19-hydroxy-14,18-dioxo-17-oxa-3,13-diazapentacyclo[11.8.0.0^{2,11}.0^{4,9}.0^{15,20}]henicosa-1(21),2(11),3,5,7,9,15(20)-heptaen-7-yl [1,4'-bipiperidine]-1'-carboxylate Hydrochloride

71. (4s)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl [1,4'-bipiperidine]-1'-carboxylic Acid Ester Hydrochloride

72. (4s)-4,11-diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl [1,4'-bipiperidine]-1'-carboxylate Hydrochloride

73. (s)-4,11-diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl[1,4'-bipiperidine]-1'-carboxylatehydrochloride

74. [(19s)-10,19-diethyl-19-hydroxy-14,18-dioxo-17-oxa-3,13-diazapentacyclo[11.8.0.02,11.04,9.015,20]henicosa-1(21),2,4(9),5,7,10,15(20)-heptaen-7-yl] 4-piperidin-1-ylpiperidine-1-carboxylate Hydrochloride

75. [1, 4,11-diethyl-3,4,12, 14-tetrahydro-4-hydroxy-3,14-dioxo-1h-pyrano[3',4':6,7] Indolizino[1,2-b]quinolin-9-yl Ester, Monohydrochloride (s)-

76. [1,4'-bipiperidine]-1'-carboxylic Acid,(4s)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl Ester, Monohydrochloride

77. 1-[1-({[(4s)-4,11-diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl]oxy}carbonyl)piperidin-4-yl]piperidin-1-ium Chloride

2.3.3 Other Synonyms

1. Camptosar

2. Campto

3. Irinotecan

4. Hy-16562

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 623.1 g/mol
Molecular Formula C33H39ClN4O6
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count8
Rotatable Bond Count5
Exact Mass622.2558127 g/mol
Monoisotopic Mass622.2558127 g/mol
Topological Polar Surface Area113 Ų
Heavy Atom Count44
Formal Charge0
Complexity1200
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameIrinotecan hydrochloride
Drug LabelIrinotecan hydrochloride injection is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan hydrochloride was clinically investigated as CPT-11. Irinotecan hydrochloride injection is supplied as a sterile, pale yellow, clear, aqu...
Active IngredientIrinotecan hydrochloride
Dosage FormInjectable
Routeinjection; Injection
Strength20mg/ml; 100mg/5ml (20mg/ml); 500mg/25ml (20mg/ml); 100mg/5ml; 40mg/2ml (20mg/ml)
Market StatusPrescription
CompanyPliva Lachema; Hospira; Teva Parenteral; Fresenius Kabi Oncol; Accord Hlthcare; Jiangsu Hengrui Med; Hikma Farmaceutica; Teva Pharms Usa; Cipla; Hisun Pharm Hangzhou; Sun Pharma Global; Actavis Elizabeth; Emcure Pharms; Mustafa Nevzat Ilac; Fresenius Kabi

2 of 2  
Drug NameIrinotecan hydrochloride
Drug LabelIrinotecan hydrochloride injection is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan hydrochloride was clinically investigated as CPT-11. Irinotecan hydrochloride injection is supplied as a sterile, pale yellow, clear, aqu...
Active IngredientIrinotecan hydrochloride
Dosage FormInjectable
Routeinjection; Injection
Strength20mg/ml; 100mg/5ml (20mg/ml); 500mg/25ml (20mg/ml); 100mg/5ml; 40mg/2ml (20mg/ml)
Market StatusPrescription
CompanyPliva Lachema; Hospira; Teva Parenteral; Fresenius Kabi Oncol; Accord Hlthcare; Jiangsu Hengrui Med; Hikma Farmaceutica; Teva Pharms Usa; Cipla; Hisun Pharm Hangzhou; Sun Pharma Global; Actavis Elizabeth; Emcure Pharms; Mustafa Nevzat Ilac; Fresenius Kabi

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Topoisomerase I Inhibitors

Compounds that inhibit the activity of DNA TOPOISOMERASE I. (See all compounds classified as Topoisomerase I Inhibitors.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Topoisomerase Inhibitors [MoA]; Topoisomerase Inhibitor [EPC]

API Reference Price

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HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1680114600,"product":"IRINOTECAN HYDROCHLORIDE TRIHYDRATE BATCH NO-71134AA113","address":"PLOT NO. 3, PHARMEZ, SEZ, SARKEHJ","city":"TAL- SANAND, DIST- AHMEDABAD","supplier":"SCION PHARMA TAIWAN LTD","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"17.00","actualQuantity":"17","unit":"KGS","unitRateFc":"40437.5","totalValueFC":"699552.8","currency":"USD","unitRateINR":"3384616.4","date":"30-Mar-2023","totalValueINR":"57538479","totalValueInUsd":"699552.8","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29349990","bill_no":"1001328","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"N\/A","customerAddress":"PLOT NO. 3, PHARMEZ, SEZ, SARKEHJ"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690828200,"product":"IRINOTECAN HCL IRINOTECAN HYDROCHLORIDE - BATCCH NO:3E004GE8 - QTY 250 G - AS PER DOCUMENT","address":"NA","city":"NA","supplier":"SHANDONG QILU MEDICINES IMPORT EXPORT CO LIMITED","supplierCountry":"CHINA","foreign_port":"NA","customer":"AUXILLA PHARMACEUTICALS AND ","customerCountry":"INDIA","quantity":"0.25","actualQuantity":"0.25","unit":"KGS","unitRateFc":"25000","totalValueFC":"6295","currency":"USD","unitRateINR":"2064961.8","date":"01-Aug-2023","totalValueINR":"521455","totalValueInUsd":"6295","indian_port":"AHEMDABAD AIR","hs_no":"29349990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"NA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707330600,"product":"7-ETHYL-10-HYDROXY CAMPTOTHECINE","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"UNIBEST INDUSTRIAL CO ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"8450","totalValueFC":"427470.9","currency":"USD","unitRateINR":"709377.5","date":"08-Feb-2024","totalValueINR":"35468875","totalValueInUsd":"427470.9","indian_port":"Madras Air","hs_no":"29339990","bill_no":"2052420","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"11F BLDG1 YINCHEN INTERNATIONALMANSION NINGBOSDNF CHINA","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,"}]
29-Jan-2021
27-Aug-2024
KGS
overview
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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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INTERMEDIATES SUPPLIERS

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

CAS Number : 110351-94-5

End Use API : Irinotecan Hydrochloride

About The Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commer...

Cohance

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

CAS Number : 35364-15-9

End Use API : Irinotecan Hydrochloride

About The Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commer...

Cohance

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

CAS Number : 86639-52-3

End Use API : Irinotecan Hydrochloride

About The Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commer...

Cohance

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

CAS Number : 35364-15-9

End Use API : Irinotecan Hydrochloride

About The Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commer...

Cohance

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

CAS Number : 4897-50-1

End Use API : Irinotecan Hydrochloride

About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...

Tagoor Laboratories

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

CAS Number : 4897-50-1

End Use API : Irinotecan Hydrochloride

About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...

Tagoor Laboratories

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

CAS Number : 4876-60-2

End Use API : Irinotecan Hydrochloride

About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...

Tagoor Laboratories

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

CAS Number : 4876-60-2

End Use API : Irinotecan Hydrochloride

About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...

Tagoor Laboratories

09

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
Not Confirmed
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CAS Number : 4897-50-1

End Use API : Irinotecan Hydrochloride

About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...

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10

2024 ACI Convention
Not Confirmed
arrow
2024 ACI Convention
Not Confirmed
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CAS Number : 19685-09-7

End Use API : Irinotecan Hydrochloride

About The Company : Chengdu Yazhong Bio-pharmaceutical Co., Ltd., founded in 2002, is a leading company with plant extracts, APIs and medical intermediates. Our company is equipped...

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FDA Orange Book

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01

ACCORD HLTHCARE

United Kingdom
SupplySide West 2024
Not Confirmed
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ACCORD HLTHCARE

United Kingdom
arrow
SupplySide West 2024
Not Confirmed

IRINOTECAN HYDROCHLORIDE

Brand Name : IRINOTECAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 40MG/2ML (20MG/ML)

Approval Date : 2008-11-21

Application Number : 79068

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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02

EUGIA PHARMA

India
SupplySide West 2024
Not Confirmed
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EUGIA PHARMA

India
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Not Confirmed

IRINOTECAN HYDROCHLORIDE

Brand Name : IRINOTECAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100MG/5ML (20MG/ML)

Approval Date : 2020-11-02

Application Number : 213278

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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03

CHARTWELL RX

U.S.A
SupplySide West 2024
Not Confirmed
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CHARTWELL RX

U.S.A
arrow
SupplySide West 2024
Not Confirmed

IRINOTECAN HYDROCHLORIDE

Brand Name : IRINOTECAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100MG/5ML (20MG/ML)

Approval Date : 2010-04-15

Application Number : 78953

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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04

HOSPIRA

U.S.A
SupplySide West 2024
Not Confirmed
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HOSPIRA

U.S.A
arrow
SupplySide West 2024
Not Confirmed

IRINOTECAN HYDROCHLORIDE

Brand Name : IRINOTECAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100MG/5ML (20MG/ML)

Approval Date : 2008-02-27

Application Number : 77915

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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05

PFIZER INC

U.S.A
SupplySide West 2024
Not Confirmed
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PFIZER INC

U.S.A
arrow
SupplySide West 2024
Not Confirmed

IRINOTECAN HYDROCHLORIDE

Brand Name : CAMPTOSAR

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 40MG/2ML (20MG/ML)

Approval Date : 1996-06-14

Application Number : 20571

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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06

SupplySide West 2024
Not Confirmed
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SupplySide West 2024
Not Confirmed

IRINOTECAN HYDROCHLORIDE

Brand Name : IRINOTECAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100MG/5ML (20MG/ML)

Approval Date : 2016-05-03

Application Number : 203380

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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07

SupplySide West 2024
Not Confirmed
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SupplySide West 2024
Not Confirmed

IRINOTECAN HYDROCHLORIDE

Brand Name : IRINOTECAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 300MG/15ML (20MG/ML)

Approval Date : 2016-05-03

Application Number : 203380

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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08

SupplySide West 2024
Not Confirmed
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arrow
SupplySide West 2024
Not Confirmed

IRINOTECAN HYDROCHLORIDE

Brand Name : IRINOTECAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 40MG/2ML (20MG/ML)

Approval Date : 2008-12-24

Application Number : 78753

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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09

SupplySide West 2024
Not Confirmed
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SupplySide West 2024
Not Confirmed

IRINOTECAN HYDROCHLORIDE

Brand Name : IRINOTECAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100MG/5ML (20MG/ML)

Approval Date : 2008-12-24

Application Number : 78753

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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10

ZENNOVA

U.S.A
SupplySide West 2024
Not Confirmed
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ZENNOVA

U.S.A
arrow
SupplySide West 2024
Not Confirmed

IRINOTECAN HYDROCHLORIDE

Brand Name : IRINOTECAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 40MG/2ML (20MG/ML)

Approval Date : 2011-05-13

Application Number : 90393

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;INJECTION - 100MG/5ML (20...DOSAGE - INJECTABLE;INJECTION - 100MG/5ML (20MG/ML)

USFDA APPLICATION NUMBER - 20571

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DOSAGE - INJECTABLE;INJECTION - 300MG/15ML (2...DOSAGE - INJECTABLE;INJECTION - 300MG/15ML (20MG/ML)

USFDA APPLICATION NUMBER - 20571

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DOSAGE - INJECTABLE;INJECTION - 40MG/2ML (20M...DOSAGE - INJECTABLE;INJECTION - 40MG/2ML (20MG/ML)

USFDA APPLICATION NUMBER - 20571

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DOSAGE - INJECTABLE, LIPOSOMAL;INTRAVENOUS - ...DOSAGE - INJECTABLE, LIPOSOMAL;INTRAVENOUS - EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)

USFDA APPLICATION NUMBER - 207793

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Patents & EXCLUSIVITIES

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US Patents

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01

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IPSEN

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IRINOTECAN HYDROCHLORIDE

US Patent Number : 8703181

Drug Substance Claim :

Drug Product Claim :

Application Number : 207793

Patent Use Code : U-1434

Delist Requested :

Patent Use Description : TREATMENT OF PANCREATI...

Patent Expiration Date : 2025-05-02

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02

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IRINOTECAN HYDROCHLORIDE

US Patent Number : 10456360

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 207793

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2036-10-15

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IRINOTECAN HYDROCHLORIDE

US Patent Number : 9782349

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 207793

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-05-02

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04

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IPSEN

France
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IRINOTECAN HYDROCHLORIDE

US Patent Number : 9452162

Drug Substance Claim :

Drug Product Claim :

Application Number : 207793

Patent Use Code : U-1899

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-06-12

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05

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IPSEN

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IRINOTECAN HYDROCHLORIDE

US Patent Number : 9364473

Drug Substance Claim :

Drug Product Claim :

Application Number : 207793

Patent Use Code : U-1856

Delist Requested :

Patent Use Description : TREATMENT OF METASTATI...

Patent Expiration Date : 2033-06-12

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06

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IPSEN

France
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SupplySide West 2024
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IRINOTECAN HYDROCHLORIDE

US Patent Number : 12059497

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 207793

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2036-10-15

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07

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IPSEN

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IRINOTECAN HYDROCHLORIDE

US Patent Number : 10980795

Drug Substance Claim :

Drug Product Claim :

Application Number : 207793

Patent Use Code : U-1848

Delist Requested :

Patent Use Description : TREATMENT OF METASTATI...

Patent Expiration Date : 2033-06-12

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IPSEN

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IRINOTECAN HYDROCHLORIDE

US Patent Number : 9339497

Drug Substance Claim :

Drug Product Claim :

Application Number : 207793

Patent Use Code : U-1848

Delist Requested :

Patent Use Description : TREATMENT OF METASTATI...

Patent Expiration Date : 2033-06-12

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09

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IPSEN

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IRINOTECAN HYDROCHLORIDE

US Patent Number : 8147867

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 207793

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-08-29

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10

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IRINOTECAN HYDROCHLORIDE

US Patent Number : 11369597

Drug Substance Claim :

Drug Product Claim :

Application Number : 207793

Patent Use Code : U-1848

Delist Requested :

Patent Use Description : TREATMENT OF METASTATI...

Patent Expiration Date : 2033-06-12

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