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Approved Drug Products containing DSSTox_CID_3636 listed in the FDA Orange Book. Original Data : FDA Website

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Product

DSSTox_CID_3636
FDA Orange Book

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DSSTox_CID_3636

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

132 API Suppliers, 41 USDMF, 40 CEP/COS, 19 JDMF, 37 EU WC, 43 KDMF, 20 NDC API, 73 Listed Suppliers, $ API Reference Price

132 API Suppliers
41 USDMF
40 CEP/COS
19 JDMF
37 EU WC
43 KDMF
20 NDC API
73 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

45 API Suppliers

45 API Suppliers

FINISHED DOSAGE FORMULATIONS

869 FDF Dossiers, 104 FDA Orange Book, 410 Europe, 64 Canada, 28 Australia, 65 South Africa, 198 Listed Dossiers

869 FDF Dossiers
104 FDA Orange Book
410 Europe
64 Canada
28 Australia
65 South Africa
198 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 20MG, TABLET;ORAL - 40MG, TABLET;ORAL - 80MG, TABLET;ORAL - 12.5MG;40MG, TABLET;ORAL - 12.5MG;80MG, TABLET;ORAL - 25MG;80MG, TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 20MG
TABLET;ORAL - 40MG
TABLET;ORAL - 80MG
TABLET;ORAL - 12.5MG;40MG
TABLET;ORAL - 12.5MG;80MG
TABLET;ORAL - 25MG;80MG
TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Rochem International Inc, 18 SPI Pharma, 2 DKSH, 2 Jai Radhe Sales, 8 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 1 Aeon Procare, 2 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 14 BASF, 10 Corel Pharma Chem, 7 DFE Pharma, 8 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 NEWEDGE Overseas, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 6 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 29 Roquette, 7 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 3 Ulanqab Kema New Material, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

92 Fillers, Diluents & Binders, 47 Direct Compression, 45 Coating Systems & Additives, 44 Disintegrants & Superdisintegrants, 26 Granulation, 24 Controlled & Modified Release, 21 Lubricants & Glidants, 20 Chewable & Orodispersible Aids, 20 Co-Processed Excipients, 19 Thickeners and Stabilizers, 18 Taste Masking, 15 Film Formers & Plasticizers, 11 Solubilizers, 9 Parenteral, 6 API Stability Enhancers, 5 Empty Capsules, 4 Emulsifying Agents, 4 Vegetarian Capsules, 3 Rheology Modifiers, 3 Coloring Agents, 1 Soft Gelatin

92 Fillers, Diluents & Binders
47 Direct Compression
45 Coating Systems & Additives
44 Disintegrants & Superdisintegrants
26 Granulation
24 Controlled & Modified Release
21 Lubricants & Glidants
20 Chewable & Orodispersible Aids
20 Co-Processed Excipients
19 Thickeners and Stabilizers
18 Taste Masking
15 Film Formers & Plasticizers
11 Solubilizers
9 Parenteral
6 API Stability Enhancers
5 Empty Capsules
4 Emulsifying Agents
4 Vegetarian Capsules
3 Rheology Modifiers
3 Coloring Agents
1 Soft Gelatin

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 41 NEWS #PharmaBuzz

5 DATA COMPILATION #PharmaFlow
41 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 372 Finished Drug Prices, 7 Annual Reports

2 US Medicaid Prescriptions
372 Finished Drug Prices
7 Annual Reports

MARKET PLACE

31 APIs, 12 FDF Dossiers

31 APIs
12 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 Health Canada Patents

6 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP, 19 Others

3 EDQM
2 USP
19 Others

ANALYTICAL

2 BioAnalytical Methods, 2 Analytical Methods

2 BioAnalytical Methods
2 Analytical Methods

$ API Ref.Price (USD/KG) : 146 Xls

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104 All

01 10ALEMBIC

02 3AMNEAL PHARMS

03 6AUROBINDO PHARMA

04 10BOEHRINGER INGELHEIM

05 3CADILA PHARMS LTD

06 3CHARTWELL RX

07 6GLENMARK PHARMS LTD

08 3HETERO LABS LTD V

09 3HISUN PHARM HANGZHOU

10 3INVENTIA

11 3JUBILANT GENERICS

12 7LUPIN LTD

13 3MACLEODS PHARMS LTD

14 3MICRO LABS

15 7MYLAN

16 3NATCO

17 6PRINSTON INC

18 3SANDOZ

19 10TORRENT

20 3WATSON LABS FLORIDA

21 6ZYDUS PHARMS

filter Dosage Reset all filters

104 All

01 3TABLET; ORAL

02 101TABLET;ORAL

filter Regulatory Info Reset all filters

104 All

01 30DISCN

02 71RX

03 3Blank

filter Brand Name Reset all filters

104 All

01 3MICARDIS

02 3MICARDIS HCT

03 48TELMISARTAN

04 16TELMISARTAN AND AMLODIPINE

05 27TELMISARTAN AND HYDROCHLOROTHIAZIDE

06 3TELMISARTAN; HYDROCHLOROTHIAZIDE

07 4TWYNSTA

filter RLD Reset all filters

104 All

01 91No

02 10Yes

03 3Blank

Octavius Telmisartan

FDF Dossiers
FDA Orange Book
Europe
Canada
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01

BOEHRINGER INGELHEIM

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RLD : Yes

TE Code : AB

TELMISARTAN

Brand Name : MICARDIS

Dosage Form : TABLET;ORAL

Dosage Strength : 40MG

Approval Date : 1998-11-10

Application Number : 20850

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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RLD : Yes

TE Code : AB

TELMISARTAN

Brand Name : MICARDIS

Dosage Form : TABLET;ORAL

Dosage Strength : 80MG

Approval Date : 1998-11-10

Application Number : 20850

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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BOEHRINGER INGELHEIM

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RLD : Yes

TE Code : AB

TELMISARTAN

Brand Name : MICARDIS

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 2000-04-04

Application Number : 20850

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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RLD : Yes

TE Code : AB

HYDROCHLOROTHIAZIDE; TELMISARTAN

Brand Name : MICARDIS HCT

Dosage Form : TABLET;ORAL

Dosage Strength : 12.5MG;40MG

Approval Date : 2000-11-17

Application Number : 21162

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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RLD : Yes

TE Code : AB

HYDROCHLOROTHIAZIDE; TELMISARTAN

Brand Name : MICARDIS HCT

Dosage Form : TABLET;ORAL

Dosage Strength : 12.5MG;80MG

Approval Date : 2000-11-17

Application Number : 21162

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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RLD : Yes

TE Code : AB

HYDROCHLOROTHIAZIDE; TELMISARTAN

Brand Name : MICARDIS HCT

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG;80MG

Approval Date : 2004-04-19

Application Number : 21162

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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RLD : Yes

TE Code :

AMLODIPINE BESYLATE; TELMISARTAN

Brand Name : TWYNSTA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2009-10-16

Application Number : 22401

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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RLD : Yes

TE Code :

AMLODIPINE BESYLATE; TELMISARTAN

Brand Name : TWYNSTA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2009-10-16

Application Number : 22401

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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BOEHRINGER INGELHEIM

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RLD : Yes

TE Code :

AMLODIPINE BESYLATE; TELMISARTAN

Brand Name : TWYNSTA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2009-10-16

Application Number : 22401

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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RLD : Yes

TE Code :

AMLODIPINE BESYLATE; TELMISARTAN

Brand Name : TWYNSTA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2009-10-16

Application Number : 22401

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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