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

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Levitra
FDA Orange Book

With Fermion, start the journey of your innovative API.

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Suanfarma, at the Core of a Better Life.

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pharmacompass-1-m-2026-03-23

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

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Vardenafil Hydrochloride

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pharmacompass-2-m-2026-03-23

Levitra

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

42 API Suppliers, 7 USDMF, 5 CEP/COS, 2 JDMF, 4 EU WC, 2 KDMF, 24 NDC API, 22 Listed Suppliers, $ API Reference Price

42 API Suppliers
7 USDMF
5 CEP/COS
2 JDMF
4 EU WC
2 KDMF
24 NDC API
22 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

7 Drugs in Development

7 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

258 FDF Dossiers, 32 FDA Orange Book, 185 Europe, 12 Canada, 8 South Africa, 21 Listed Dossiers

258 FDF Dossiers
32 FDA Orange Book
185 Europe
12 Canada
8 South Africa
21 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TABLET, ORALLY DISINTEGRATING;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, ORALLY DISINTEGRATING;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 15 SPI Pharma, 5 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Dr. Paul Lohmann GmbH & Co. KGaA, 1 ACG Worldwide, 3 Actylis, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Esteem Industries, 1 Finar, 6 Gangwal Chemicals, 4 Ideal Cures, 1 Ingredion Pharma Solutions, 11 Kerry, 1 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 1 Neelkanth MineChem, 2 Nitika Pharmaceutical Specialities, 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 Silverline Chemicals, 2 The Dow Chemical Company, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

41 Fillers, Diluents & Binders, 39 Coating Systems & Additives, 18 Direct Compression, 18 Controlled & Modified Release, 17 Chewable & Orodispersible Aids, 17 Taste Masking, 16 Thickeners and Stabilizers, 13 Film Formers & Plasticizers, 11 Granulation, 10 Lubricants & Glidants, 10 Co-Processed Excipients, 9 Disintegrants & Superdisintegrants, 8 Topical, 6 Parenteral, 6 Solubilizers, 5 Empty Capsules, 4 Emulsifying Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 2 Rheology Modifiers, 2 Coloring Agents, 1 Soft Gelatin

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

DIGITAL CONTENT

19 News #PharmaBuzz

19 News #PharmaBuzz

GLOBAL SALES INFORMATION

5 US Medicaid Prescriptions, 17 Regulatory FDF Prices, 2 Annual Reports

5 US Medicaid Prescriptions
17 Regulatory FDF Prices
2 Annual Reports

MARKET PLACE

13 APIs

13 APIs

PATENTS & EXCLUSIVITIES

5 US Patents, 6 Health Canada Patents

5 US Patents
6 Health Canada Patents

REF. STANDARDS & IMPURITIES

13 Others

13 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 1,250 Xls

Filters

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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

List of Suppliers

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01

WATSON LABS TEVA

CGT Asia

Not Confirmed

WATSON LABS TEVA

CGT Asia

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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 :

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02

BAYER HLTHCARE

CGT Asia

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BAYER HLTHCARE

CGT Asia

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Digital Content

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

CGT Asia

Not Confirmed

BAYER HLTHCARE

CGT Asia

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Digital Content

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

Corporate PDF

04

BAYER HLTHCARE

CGT Asia

Not Confirmed

BAYER HLTHCARE

CGT Asia

Not Confirmed

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Digital Content

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

CGT Asia

Not Confirmed

BAYER HLTHCARE

CGT Asia

Not Confirmed

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Digital Content

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 :

Portfolio PDF

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06

BAYER HLTHCARE

CGT Asia

Not Confirmed

BAYER HLTHCARE

CGT Asia

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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

CGT Asia

Not Confirmed

TEVA PHARMS

CGT Asia

Not Confirmed

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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

Portfolio PDF

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08

TEVA PHARMS

CGT Asia

Not Confirmed

TEVA PHARMS

CGT Asia

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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

CGT Asia

Not Confirmed

TEVA PHARMS

CGT Asia

Not Confirmed

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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

CGT Asia

Not Confirmed

TEVA PHARMS

CGT Asia

Not Confirmed

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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

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Product Web Link

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.