Tolvaptan | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Tolvaptan
FDA Orange Book

AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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

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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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FAMAR CDMO- From early development to commercial manufacturing.

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evonik-m-2025-09-08

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Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

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Tolvaptan

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

40 API Suppliers, 17 USDMF, 8 JDMF, 6 EU WC, 5 KDMF, 7 NDC API, 17 Listed Suppliers, $ API Reference Price

40 API Suppliers
17 USDMF
8 JDMF
6 EU WC
5 KDMF
7 NDC API
17 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

58 Drugs in Development

58 Drugs in Development

INTERMEDIATES

13 Intermediate Suppliers

13 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

89 FDF Dossiers, 24 FDA Orange Book, 37 Europe, 12 Canada, 16 Australia

89 FDF Dossiers
24 FDA Orange Book
37 Europe
12 Canada
16 Australia

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 3 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 DFE Pharma, 3 Gangwal Chemicals, 1 Ideal Cures, 2 Ingredion Pharma Solutions, 10 Kerry, 1 Keval Exports, 9 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 1 Pharmatrans-Sanaq, 3 Pluviaendo, 2 Prachin Chemical, 13 Roquette, 1 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 8 Sigachi Industries, 2 Silverline Chemicals, 2 Vasa Pharmachem

4 SPI Pharma
3 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
4 DFE Pharma
3 Gangwal Chemicals
1 Ideal Cures
2 Ingredion Pharma Solutions
10 Kerry
1 Keval Exports
9 Microlex e.U
2 Nitika Pharmaceutical Specialities
1 Pharmatrans-Sanaq
3 Pluviaendo
2 Prachin Chemical
13 Roquette
1 Seppic
3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
8 Sigachi Industries
2 Silverline Chemicals
2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

38 Fillers, Diluents & Binders, 16 Direct Compression, 12 Granulation, 10 Co-Processed Excipients, 9 Thickeners and Stabilizers, 9 Lubricants & Glidants, 8 Disintegrants & Superdisintegrants, 6 Chewable & Orodispersible Aids, 5 Taste Masking, 3 Controlled & Modified Release, 2 Coating Systems & Additives, 1 Rheology Modifiers, 1 Emulsifying Agents, 1 Parenteral, 1 Film Formers & Plasticizers

38 Fillers, Diluents & Binders
16 Direct Compression
12 Granulation
10 Co-Processed Excipients
9 Thickeners and Stabilizers
9 Lubricants & Glidants
8 Disintegrants & Superdisintegrants
6 Chewable & Orodispersible Aids
5 Taste Masking
3 Controlled & Modified Release
2 Coating Systems & Additives
1 Rheology Modifiers
1 Emulsifying Agents
1 Parenteral
1 Film Formers & Plasticizers

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 22 News #PharmaBuzz

1 Data Compilation #PharmaFlow
22 News #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 33 Regulatory FDF Prices, 18 Annual Reports

6 US Medicaid Prescriptions
33 Regulatory FDF Prices
18 Annual Reports

MARKET PLACE

10 APIs, 3 FDF Dossiers

10 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

16 US Patents, 10 US Exclusivities

16 US Patents
10 US Exclusivities

REF. STANDARDS & IMPURITIES

4 USP

4 USP

$ API Ref.Price (USD/KG) : 9,186 Xls

Filters

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Filters

FILTER :

filter Applicant Reset all filters

24 All

01 3ALKEM LABS LTD

02 2APOTEX

03 2HETERO LABS LTD V

04 5LUPIN LTD

05 2MSN

06 8OTSUKA

07 2PH HEALTH

filter Dosage Reset all filters

24 All

01 24TABLET;ORAL

filter Regulatory Info Reset all filters

24 All

01 1DISCN

02 23RX

filter Brand Name Reset all filters

24 All

01 5JYNARQUE

02 3SAMSCA

03 16TOLVAPTAN

filter RLD Reset all filters

24 All

01 16No

02 8Yes

List of Suppliers

Product Main Page

01

HETERO LABS LTD V

ChemOutsourcing

Not Confirmed

HETERO LABS LTD V

ChemOutsourcing

Not Confirmed

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Digital Content

RLD : No

TE Code : AB1

Brand Name : TOLVAPTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG

Approval Date : 2021-07-16

Application Number : 205646

RX/OTC/DISCN : RX

RLD : No

TE Code : AB1

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

HETERO LABS LTD V

ChemOutsourcing

Not Confirmed

HETERO LABS LTD V

ChemOutsourcing

Not Confirmed

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Digital Content

RLD : No

TE Code : AB1

Brand Name : TOLVAPTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG

Approval Date : 2022-09-06

Application Number : 205646

RX/OTC/DISCN : RX

RLD : No

TE Code : AB1

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

OTSUKA

ChemOutsourcing

Not Confirmed

OTSUKA

ChemOutsourcing

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB1

Brand Name : SAMSCA

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG

Approval Date : 2009-05-19

Application Number : 22275

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB1

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

OTSUKA

ChemOutsourcing

Not Confirmed

OTSUKA

ChemOutsourcing

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB1

Brand Name : SAMSCA

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG

Approval Date : 2009-05-19

Application Number : 22275

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB1

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

OTSUKA

ChemOutsourcing

Not Confirmed

OTSUKA

ChemOutsourcing

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

Brand Name : SAMSCA

Dosage Form : TABLET;ORAL

Dosage Strength : 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2009-05-19

Application Number : 22275

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

OTSUKA

ChemOutsourcing

Not Confirmed

OTSUKA

ChemOutsourcing

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB2

Brand Name : JYNARQUE

Dosage Form : TABLET;ORAL

Dosage Strength : 15MG

Approval Date : 2018-04-23

Application Number : 204441

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB2

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

OTSUKA

ChemOutsourcing

Not Confirmed

OTSUKA

ChemOutsourcing

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB2

Brand Name : JYNARQUE

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG

Approval Date : 2018-04-23

Application Number : 204441

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB2

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

OTSUKA

ChemOutsourcing

Not Confirmed

OTSUKA

ChemOutsourcing

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB

Brand Name : JYNARQUE

Dosage Form : TABLET;ORAL

Dosage Strength : 45MG

Approval Date : 2018-04-23

Application Number : 204441

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

OTSUKA

ChemOutsourcing

Not Confirmed

OTSUKA

ChemOutsourcing

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Post an Enquiry

Digital Content

RLD : Yes

TE Code : AB2

Brand Name : JYNARQUE

Dosage Form : TABLET;ORAL

Dosage Strength : 60MG

Approval Date : 2018-04-23

Application Number : 204441

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB2

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

OTSUKA

ChemOutsourcing

Not Confirmed

OTSUKA

ChemOutsourcing

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

RLD : Yes

TE Code : AB

Brand Name : JYNARQUE

Dosage Form : TABLET;ORAL

Dosage Strength : 90MG

Approval Date : 2018-04-23

Application Number : 204441

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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