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

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Product

Vardenafil Hydrochloride
FDA Orange Book

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2024-09-09

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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xyz-pharma-m-2024-09-09

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Vardenafil Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 6 USDMF, 5 CEP/COS, 2 JDMF, 8 EU WC, 2 KDMF, 9 NDC API, 21 Listed Suppliers, $ API Reference Price

27 API Suppliers
6 USDMF
5 CEP/COS
2 JDMF
8 EU WC
2 KDMF
9 NDC API
21 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 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

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

102 FDF Dossiers, 32 FDA Orange Book, 39 Europe, 6 Canada, 5 South Africa, 20 Listed Dossiers

102 FDF Dossiers
32 FDA Orange Book
39 Europe
6 Canada
5 South Africa
20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, ORALLY DISINTEGRATING;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, ORALLY DISINTEGRATING;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 14 SPI Pharma, 2 Seqens, 3 DKSH, 7 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 3 Actylis, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Finar, 6 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 17 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 21 Roquette, 6 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 8 Sigachi Industries, 2 The Dow Chemical Company, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives, 42 Fillers, Diluents & Binders, 24 Controlled & Modified Release, 22 Direct Compression, 17 Thickeners and Stabilizers, 16 Taste Masking, 14 Chewable & Orodispersible Aids, 14 Film Formers & Plasticizers, 11 Lubricants & Glidants, 11 Co-Processed Excipients, 11 Granulation, 8 Parenteral, 7 Topical, 6 Disintegrants & Superdisintegrants, 5 Empty Capsules, 5 API Stability Enhancers, 5 Solubilizers, 4 Emulsifying Agents, 4 Vegetarian Capsules, 4 Coloring Agents, 2 Rheology Modifiers, 1 Soft Gelatin

45 Coating Systems & Additives
42 Fillers, Diluents & Binders
24 Controlled & Modified Release
22 Direct Compression
17 Thickeners and Stabilizers
16 Taste Masking
14 Chewable & Orodispersible Aids
14 Film Formers & Plasticizers
11 Lubricants & Glidants
11 Co-Processed Excipients
11 Granulation
8 Parenteral
7 Topical
6 Disintegrants & Superdisintegrants
5 Empty Capsules
5 API Stability Enhancers
5 Solubilizers
4 Emulsifying Agents
4 Vegetarian Capsules
4 Coloring Agents
2 Rheology Modifiers
1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 18 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
18 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 26 Finished Drug Prices, 2 Annual Reports

1 US Medicaid Prescriptions
26 Finished Drug Prices
2 Annual Reports

MARKET PLACE

12 APIs

12 APIs

PATENTS & EXCLUSIVITIES

5 US Patents, 5 Health Canada Patents

5 US Patents
5 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 11 Others

2 USP
11 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 2,164 Xls

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32 All

01 5ALEMBIC

02 5BAYER HLTHCARE

03 4CROSSMEDIKA SA

04 5MACLEODS PHARMS LTD

05 1PAR PHARM INC

06 3STEVENS J

07 4TEVA PHARMS

08 1WATSON LABS TEVA

09 4ZYDUS PHARMS

filter Dosage Reset all filters

32 All

01 5TABLET, ORALLY DISINTEGRATING;ORAL

02 27TABLET;ORAL

filter Regulatory Info Reset all filters

32 All

01 8DISCN

02 22RX

03 2Blank

filter Brand Name Reset all filters

32 All

01 4LEVITRA

02 1STAXYN

03 27VARDENAFIL HYDROCHLORIDE

filter RLD Reset all filters

32 All

01 25No

02 5Yes

03 2Blank

FDF Dossiers
FDA Orange Book
Europe
Canada
South Africa
Listed Dossiers

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01

WATSON LABS TEVA

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WATSON LABS TEVA

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Digital Content

RLD :

TE Code :

VARDENAFIL HYDROCHLORIDE

Brand Name : VARDENAFIL HYDROCHLORIDE

Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL

Dosage Strength : 10MG

Approval Date :

Application Number : 203689

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

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Digital Content

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02

BAYER HLTHCARE

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RLD : Yes

TE Code :

VARDENAFIL HYDROCHLORIDE

Brand Name : LEVITRA

Dosage Form : TABLET;ORAL

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

Approval Date : 2003-08-19

Application Number : 21400

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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03

BAYER HLTHCARE

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RLD : Yes

TE Code :

VARDENAFIL HYDROCHLORIDE

Brand Name : LEVITRA

Dosage Form : TABLET;ORAL

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

Approval Date : 2003-08-19

Application Number : 21400

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

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04

BAYER HLTHCARE

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RLD : Yes

TE Code :

VARDENAFIL HYDROCHLORIDE

Brand Name : LEVITRA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2003-08-19

Application Number : 21400

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

BAYER HLTHCARE

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RLD : Yes

TE Code :

VARDENAFIL HYDROCHLORIDE

Brand Name : LEVITRA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2003-08-19

Application Number : 21400

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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Product Web Link

Digital Content

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06

BAYER HLTHCARE

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Digital Content

RLD : Yes

TE Code :

VARDENAFIL HYDROCHLORIDE

Brand Name : STAXYN

Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL

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

Approval Date : 2010-06-17

Application Number : 200179

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

TEVA PHARMS

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TEVA PHARMS

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Digital Content

RLD : No

TE Code : AB

VARDENAFIL HYDROCHLORIDE

Brand Name : VARDENAFIL HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2.5MG BASE

Approval Date : 2012-05-03

Application Number : 91347

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

TEVA PHARMS

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Digital Content

RLD : No

TE Code : AB

VARDENAFIL HYDROCHLORIDE

Brand Name : VARDENAFIL HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 2012-05-03

Application Number : 91347

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

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09

TEVA PHARMS

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TEVA PHARMS

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Digital Content

RLD : No

TE Code : AB

VARDENAFIL HYDROCHLORIDE

Brand Name : VARDENAFIL HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2012-05-03

Application Number : 91347

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

TEVA PHARMS

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TEVA PHARMS

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Digital Content

RLD : No

TE Code : AB

VARDENAFIL HYDROCHLORIDE

Brand Name : VARDENAFIL HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 20MG BASE

Approval Date : 2012-05-03

Application Number : 91347

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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