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Approved Drug Products containing Topotecan Hydrochloride listed in the FDA Orange Book. Original Data : FDA Website

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Product

Topotecan Hydrochloride
FDA Orange Book

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Bora Pharmaceuticals- Making success more certain.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Topotecan Hydrochloride

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

PRICE INFORMATION

API Reference Price, API Exports, API Imports

API Reference Price
API Exports
API Imports

INTERMEDIATES

3 API Suppliers

3 API 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- EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML), INJECTABLE;INJECTION - EQ 4MG BASE/VIAL, CAPSULE;ORAL - EQ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 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 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 Chewable & Orodispersible Aids, 10 Taste Masking, 9 Direct Compression, 8 Empty Capsules, 7 Co-Processed Excipients, 6 Coating Systems & Additives, 5 Thickeners and Stabilizers, 5 Parenteral, 3 Granulation, 3 Disintegrants & Superdisintegrants, 2 Solubilizers, 2 Coloring Agents, 2 Film Formers & Plasticizers, 1 Topical, 1 API Stability Enhancers

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

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 PHARMA

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 8DISCN

02 14RX

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

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

ACTAVIS TOTOWA

Luxepack

Not Confirmed

ACTAVIS TOTOWA

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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

Luxepack

Not Confirmed

FRESENIUS KABI USA

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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

Corporate PDF

03

FRESENIUS KABI USA

Luxepack

Not Confirmed

FRESENIUS KABI USA

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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

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MEITHEAL

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Digital Content

RLD : No

TE Code : AP

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 : RX

RLD : No

TE Code : AP

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

SAGENT PHARMS

Luxepack

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SAGENT PHARMS

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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

06

SANDOZ

Luxepack

Not Confirmed

SANDOZ

Luxepack

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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

07

SANDOZ

Luxepack

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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

08

SANDOZ

Luxepack

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 1MG BASE

Approval Date : 2007-10-11

Application Number : 20981

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Product Web Link

Digital Content

09

TEYRO LABS

Luxepack

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TEYRO LABS

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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

Corporate PDF

10

RISING PHARMA

Country

Luxepack

Not Confirmed

RISING PHARMA

Country

Luxepack

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Country

Virtual Booth

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

Virtual Booth

Digital Content

Website

Corporate PDF

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