CAS-1197-18-8 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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CAS-1197-18-8
FDA Orange Book

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CAS-1197-18-8

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

45 API Suppliers, 12 USDMF, 8 CEP/COS, 7 JDMF, 3 EU WC, 3 KDMF, 16 NDC API, 25 Listed Suppliers, $ API Reference Price

45 API Suppliers
12 USDMF
8 CEP/COS
7 JDMF
3 EU WC
3 KDMF
16 NDC API
25 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

31 Drugs in Development

31 Drugs in Development

INTERMEDIATES

9 Intermediate Suppliers

9 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

140 FDF Dossiers, 31 FDA Orange Book, 35 Europe, 17 Canada, 3 Australia, 24 South Africa, 30 Listed Dossiers

140 FDF Dossiers
31 FDA Orange Book
35 Europe
17 Canada
3 Australia
24 South Africa
30 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 100MG/ML, TABLET;ORAL - 650MG

INJECTABLE;INJECTION - 100MG/ML
TABLET;ORAL - 650MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 5 Evonik, 4 SPI Pharma, 3 DKSH, 5 Faran Shimi Pharmaceutical, 7 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 26 BASF, 13 Corel Pharma Chem, 5 DFE Pharma, 1 Finar, 8 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 30 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

72 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 32 Controlled & Modified Release, 31 Disintegrants & Superdisintegrants, 31 Direct Compression, 28 Granulation, 23 Film Formers & Plasticizers, 22 Thickeners and Stabilizers, 18 Taste Masking, 15 Solubilizers, 15 Lubricants & Glidants, 10 Topical, 10 Co-Processed Excipients, 9 Chewable & Orodispersible Aids, 7 Parenteral, 5 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Emulsifying Agents, 2 Coloring Agents, 1 Surfactant & Foaming Agents

72 Fillers, Diluents & Binders
51 Coating Systems & Additives
32 Controlled & Modified Release
31 Disintegrants & Superdisintegrants
31 Direct Compression
28 Granulation
23 Film Formers & Plasticizers
22 Thickeners and Stabilizers
18 Taste Masking
15 Solubilizers
15 Lubricants & Glidants
10 Topical
10 Co-Processed Excipients
9 Chewable & Orodispersible Aids
7 Parenteral
5 Rheology Modifiers
5 Empty Capsules
4 Vegetarian Capsules
4 API Stability Enhancers
4 Emulsifying Agents
2 Coloring Agents
1 Surfactant & Foaming Agents

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 28 News #PharmaBuzz

2 Data Compilation #PharmaFlow
28 News #PharmaBuzz

GLOBAL SALES INFORMATION

22 Regulatory FDF Prices

22 Regulatory FDF Prices

MARKET PLACE

73 APIs, 36 FDF Dossiers, 1 EXCIPIENTS, 1 CONTRACT SERVICES

73 APIs
36 FDF Dossiers
1 EXCIPIENTS
1 CONTRACT SERVICES

PATENTS & EXCLUSIVITIES

8 US Patents

8 US Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 4 JP, 3 Others

1 EDQM
4 JP
3 Others

$ API Ref.Price (USD/KG) : 71 Xls

Filters

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31 All

01 1ACTAVIS LABS FL INC

02 1AM REGENT

03 1AMNEAL

04 1AMNEAL PHARMS CO

05 1AMRING PHARMS

06 1ANI PHARMS

07 2APOTEX

08 1AUROBINDO PHARMA USA

09 1AVET LIFESCIENCES

10 1CAPLIN

11 1CHARTWELL RX

12 2EPIC PHARMA LLC

13 1EUGIA PHARMA

14 1EXELA PHARMA

15 2FRESENIUS KABI USA

16 2GLAND

17 1HERITAGE

18 1MICRO LABS

19 1MYLAN INSTITUTIONAL

20 1NEXUS

21 1PFIZER

22 1PHARMACIA AND UPJOHN

23 1PROVEPHARM SAS

24 1RISING

25 1RUBICON

26 1XGEN PHARMS

27 1ZYDUS PHARMS

filter Dosage Reset all filters

31 All

01 19INJECTABLE;INJECTION

02 5SOLUTION;INTRAVENOUS

03 7TABLET;ORAL

filter Regulatory Info Reset all filters

31 All

01 7DISCN

02 24RX

filter Brand Name Reset all filters

31 All

01 2CYKLOKAPRON

02 1LYSTEDA

03 28TRANEXAMIC ACID

filter RLD Reset all filters

31 All

01 28No

02 3Yes

Athena Tranexamic Acid

List of Suppliers

Product Main Page

01

ACTAVIS LABS FL INC

AMWC Asia-TDAC

Not Confirmed

ACTAVIS LABS FL INC

AMWC Asia-TDAC

Not Confirmed

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RLD : No

TE Code : AB

TRANEXAMIC ACID

Brand Name : TRANEXAMIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 650MG

Approval Date : 2012-12-27

Application Number : 202093

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

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02

AM REGENT

AMWC Asia-TDAC

Not Confirmed

AM REGENT

AMWC Asia-TDAC

Not Confirmed

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RLD : No

TE Code : AP

TRANEXAMIC ACID

Brand Name : TRANEXAMIC ACID

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100MG/ML

Approval Date : 2011-08-10

Application Number : 201885

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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03

AMRING PHARMS

AMWC Asia-TDAC

Not Confirmed

AMRING PHARMS

AMWC Asia-TDAC

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB

TRANEXAMIC ACID

Brand Name : LYSTEDA

Dosage Form : TABLET;ORAL

Dosage Strength : 650MG

Approval Date : 2009-11-13

Application Number : 22430

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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04

APOTEX

AMWC Asia-TDAC

Not Confirmed

APOTEX

AMWC Asia-TDAC

Not Confirmed

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RLD : No

TE Code :

TRANEXAMIC ACID

Brand Name : TRANEXAMIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 650MG

Approval Date : 2014-01-27

Application Number : 202286

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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05

EPIC PHARMA LLC

AMWC Asia-TDAC

Not Confirmed

EPIC PHARMA LLC

AMWC Asia-TDAC

Not Confirmed

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RLD : No

TE Code : AP

TRANEXAMIC ACID

Brand Name : TRANEXAMIC ACID

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100MG/ML

Approval Date : 2011-11-17

Application Number : 202373

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Portfolio PDF

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06

FRESENIUS KABI USA

AMWC Asia-TDAC

Not Confirmed

FRESENIUS KABI USA

AMWC Asia-TDAC

Not Confirmed

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RLD : No

TE Code :

TRANEXAMIC ACID

Brand Name : TRANEXAMIC ACID

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100MG/ML

Approval Date : 2012-03-02

Application Number : 91596

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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07

PHARMACIA AND UPJOHN

AMWC Asia-TDAC

Not Confirmed

PHARMACIA AND UPJOHN

AMWC Asia-TDAC

Not Confirmed

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Digital Content

RLD : No

TE Code :

TRANEXAMIC ACID

Brand Name : CYKLOKAPRON

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG

Approval Date : 1986-12-30

Application Number : 19280

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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Digital Content

08

PFIZER

AMWC Asia-TDAC

Not Confirmed

PFIZER

AMWC Asia-TDAC

Not Confirmed

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RLD : Yes

TE Code : AP

TRANEXAMIC ACID

Brand Name : CYKLOKAPRON

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100MG/ML

Approval Date : 1986-12-30

Application Number : 19281

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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09

MYLAN INSTITUTIONAL

AMWC Asia-TDAC

Not Confirmed

MYLAN INSTITUTIONAL

AMWC Asia-TDAC

Not Confirmed

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RLD : No

TE Code : AP

TRANEXAMIC ACID

Brand Name : TRANEXAMIC ACID

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100MG/ML

Approval Date : 2011-11-03

Application Number : 91657

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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10

XGEN PHARMS

AMWC Asia-TDAC

Not Confirmed

XGEN PHARMS

AMWC Asia-TDAC

Not Confirmed

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RLD : No

TE Code : AP

TRANEXAMIC ACID

Brand Name : TRANEXAMIC ACID

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100MG/ML

Approval Date : 2013-06-14

Application Number : 201580

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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