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Topotecan
FDA Orange Book

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Topotecan

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

18 API Suppliers, 8 USDMF, 1 EU WC, 4 KDMF, 3 NDC API, 12 Listed Suppliers, $ API Reference Price

18 API Suppliers
8 USDMF
1 EU WC
4 KDMF
3 NDC API
12 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

15 Drugs in Development

15 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

72 FDF Dossiers, 22 FDA Orange Book, 31 Europe, 5 Canada, 4 Australia, 4 South Africa, 6 Listed Dossiers

72 FDF Dossiers
22 FDA Orange Book
31 Europe
5 Canada
4 Australia
4 South Africa
6 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INTRAVENOUS - EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML), INJECTABLE;INJECTION - EQ 4MG BASE/VIAL, CAPSULE;ORAL - EQ 0.25MG BASE, CAPSULE;ORAL - EQ 1MG BASE

SOLUTION;INTRAVENOUS - EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
INJECTABLE;INJECTION - EQ 4MG BASE/VIAL
CAPSULE;ORAL - EQ 0.25MG BASE
CAPSULE;ORAL - EQ 1MG BASE

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 13 SPI Pharma, 6 DKSH, 1 Faran Shimi Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 1 Actylis, 2 BASF, 3 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 6 Kerry, 3 Lonza Capsugel, 2 Microlex e.U, 1 Pluviaendo, 1 Qualicaps, 5 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries

1 Rochem International Inc
13 SPI Pharma
6 DKSH
1 Faran Shimi Pharmaceutical
1 Pfanstiehl
4 ACG Worldwide
1 Actylis
2 BASF
3 Gangwal Chemicals
1 Ingredion Pharma Solutions
6 Kerry
3 Lonza Capsugel
2 Microlex e.U
1 Pluviaendo
1 Qualicaps
5 Roquette
1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
1 Sigachi Industries

EXCIPIENTS BY APPLICATIONS

21 Fillers, Diluents & Binders, 10 Taste Masking, 10 Chewable & Orodispersible Aids, 9 Direct Compression, 8 Empty Capsules, 8 Co-Processed Excipients, 6 Coating Systems & Additives, 5 Thickeners and Stabilizers, 5 Parenteral, 3 Disintegrants & Superdisintegrants, 3 Granulation, 2 Film Formers & Plasticizers, 2 Solubilizers, 2 Coloring Agents, 1 API Stability Enhancers, 1 Topical

21 Fillers, Diluents & Binders
10 Taste Masking
10 Chewable & Orodispersible Aids
9 Direct Compression
8 Empty Capsules
8 Co-Processed Excipients
6 Coating Systems & Additives
5 Thickeners and Stabilizers
5 Parenteral
3 Disintegrants & Superdisintegrants
3 Granulation
2 Film Formers & Plasticizers
2 Solubilizers
2 Coloring Agents
1 API Stability Enhancers
1 Topical

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 21 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
21 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 20 Finished Drug Prices

1 US Medicaid Prescriptions
20 Finished Drug Prices

MARKET PLACE

3 APIs, 5 FDF Dossiers

3 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Patents, 3 Health Canada Patents

2 US Patents
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 4 Others

2 USP
4 Others

$ API Ref.Price (USD/KG) : 760,431 Xls

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22 All

01 3ACCORD HLTHCARE

02 1ACTAVIS TOTOWA

03 1DASH PHARMS

04 1DR REDDYS LABS LTD

05 2FRESENIUS KABI USA

06 1HOSPIRA INC

07 2MEITHEAL

08 1NOVAST LABS

09 1RISING

10 1SAGENT PHARMS

11 3SANDOZ

12 3SANDOZ INC

13 1SUN PHARM INDS LTD

14 1TEYRO LABS

filter Dosage Reset all filters

22 All

01 2CAPSULE;ORAL

02 12INJECTABLE;INJECTION

03 8SOLUTION;INTRAVENOUS

filter Regulatory Info Reset all filters

22 All

01 9DISCN

02 13RX

filter Brand Name Reset all filters

22 All

01 3HYCAMTIN

02 3TOPOTECAN

03 16TOPOTECAN HYDROCHLORIDE

filter RLD Reset all filters

22 All

01 15No

02 7Yes

Topotecan Hydrochloride

List of Suppliers

Product Main Page

01

ACTAVIS TOTOWA

Pharmtech & Ingredients

Not Confirmed

ACTAVIS TOTOWA

Pharmtech & Ingredients

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Digital Content

RLD : No

TE Code : AP

TOPOTECAN HYDROCHLORIDE

Brand Name : TOPOTECAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 4MG BASE/VIAL

Approval Date : 2010-12-02

Application Number : 90620

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

FRESENIUS KABI USA

Pharmtech & Ingredients

Not Confirmed

FRESENIUS KABI USA

Pharmtech & Ingredients

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Digital Content

RLD : No

TE Code : AP

TOPOTECAN HYDROCHLORIDE

Brand Name : TOPOTECAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 4MG BASE/VIAL

Approval Date : 2010-11-29

Application Number : 91089

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Portfolio PDF

Product Web Link

Digital Content

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03

FRESENIUS KABI USA

Pharmtech & Ingredients

Not Confirmed

FRESENIUS KABI USA

Pharmtech & Ingredients

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Digital Content

RLD : No

TE Code :

TOPOTECAN HYDROCHLORIDE

Brand Name : TOPOTECAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 4MG BASE/VIAL

Approval Date : 2010-11-29

Application Number : 91376

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

MEITHEAL

Pharmtech & Ingredients

Not Confirmed

MEITHEAL

Pharmtech & Ingredients

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Digital Content

RLD : No

TE Code :

TOPOTECAN HYDROCHLORIDE

Brand Name : TOPOTECAN HYDROCHLORIDE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

Approval Date : 2012-12-20

Application Number : 22453

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

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05

RISING

Pharmtech & Ingredients

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RISING

Pharmtech & Ingredients

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Digital Content

RLD : No

TE Code :

TOPOTECAN HYDROCHLORIDE

Brand Name : TOPOTECAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 4MG BASE/VIAL

Approval Date : 2012-08-28

Application Number : 91542

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Digital Content

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06

SAGENT PHARMS

Pharmtech & Ingredients

Not Confirmed

SAGENT PHARMS

Pharmtech & Ingredients

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Digital Content

RLD : No

TE Code : AP

TOPOTECAN HYDROCHLORIDE

Brand Name : TOPOTECAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 4MG BASE/VIAL

Approval Date : 2011-01-26

Application Number : 91284

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

SANDOZ

Pharmtech & Ingredients

Not Confirmed

SANDOZ

Pharmtech & Ingredients

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Digital Content

RLD : Yes

TE Code : AP

TOPOTECAN HYDROCHLORIDE

Brand Name : HYCAMTIN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 4MG BASE/VIAL

Approval Date : 1996-05-28

Application Number : 20671

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

Product Web Link

Digital Content

08

SANDOZ

Pharmtech & Ingredients

Not Confirmed

SANDOZ

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Digital Content

RLD : Yes

TE Code :

TOPOTECAN HYDROCHLORIDE

Brand Name : HYCAMTIN

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 0.25MG BASE

Approval Date : 2007-10-11

Application Number : 20981

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Product Web Link

Digital Content

09

SANDOZ

Pharmtech & Ingredients

Not Confirmed

SANDOZ

Pharmtech & Ingredients

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Digital Content

RLD : Yes

TE Code :

TOPOTECAN HYDROCHLORIDE

Brand Name : HYCAMTIN

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 1MG BASE

Approval Date : 2007-10-11

Application Number : 20981

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Product Web Link

Digital Content

10

TEYRO LABS

Pharmtech & Ingredients

Not Confirmed

TEYRO LABS

Pharmtech & Ingredients

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Digital Content

RLD : No

TE Code : AP

TOPOTECAN HYDROCHLORIDE

Brand Name : TOPOTECAN HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 4MG BASE/VIAL

Approval Date : 2010-12-01

Application Number : 91199

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Product Web Link

Digital Content

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