Afatinib (diMaleate) | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Afatinib Dimaleate
FDA Orange Book

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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pharmacompass-1-m-2026-04-20

European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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pharmacompass-2-m-2026-04-20

Afatinib Dimaleate

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

30 API Suppliers, 9 USDMF, 3 EU WC, 3 KDMF, 5 NDC API, 21 Listed Suppliers

30 API Suppliers
9 USDMF
3 EU WC
3 KDMF
5 NDC API
21 Listed Suppliers

DEVELOPMENTS

81 Drugs in Development

81 Drugs in Development

INTERMEDIATES

28 Intermediate Suppliers

28 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

58 FDF Dossiers, 9 FDA Orange Book, 28 Europe, 9 Canada, 6 Australia, 3 South Africa, 3 Listed Dossiers

58 FDF Dossiers
9 FDA Orange Book
28 Europe
9 Canada
6 Australia
3 South Africa
3 Listed Dossiers

DIGITAL CONTENT

32 News #PharmaBuzz

32 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 4 Regulatory FDF Prices

1 US Medicaid Prescriptions
4 Regulatory FDF Prices

MARKET PLACE

6 APIs, 1 FDF Dossiers

6 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

30 US Patents, 15 Health Canada Patents

30 US Patents
15 Health Canada Patents

REF. STANDARDS & IMPURITIES

7 Others

7 Others

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9 All

01 3BOEHRINGER INGELHEIM

02 3MSN PHARMACEUTICALS INC

03 3SANDOZ INC

filter Dosage Reset all filters

9 All

01 3TABLET

02 6TABLET;ORAL

filter Regulatory Info Reset all filters

9 All

01 3RX

02 6Blank

filter Brand Name Reset all filters

9 All

01 6AFATINIB

02 3GILOTRIF

filter RLD Reset all filters

9 All

01 3Yes

02 6Blank

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01

BOEHRINGER INGELHEIM

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BOEHRINGER INGELHEIM

RDD

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RLD : Yes

TE Code :

AFATINIB DIMALEATE

Brand Name : GILOTRIF

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 20MG BASE

Approval Date : 2013-07-12

Application Number : 201292

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

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02

BOEHRINGER INGELHEIM

RDD

Not Confirmed

BOEHRINGER INGELHEIM

RDD

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

AFATINIB DIMALEATE

Brand Name : GILOTRIF

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 30MG BASE

Approval Date : 2013-07-12

Application Number : 201292

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

BOEHRINGER INGELHEIM

RDD

Not Confirmed

BOEHRINGER INGELHEIM

RDD

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

AFATINIB DIMALEATE

Brand Name : GILOTRIF

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 40MG BASE

Approval Date : 2013-07-12

Application Number : 201292

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

MSN PHARMACEUTICALS INC

RDD

Not Confirmed

MSN PHARMACEUTICALS INC

RDD

Not Confirmed

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Digital Content

RLD :

TE Code :

Brand Name : AFATINIB

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date :

Application Number : 210804

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

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05

MSN PHARMACEUTICALS INC

RDD

Not Confirmed

MSN PHARMACEUTICALS INC

RDD

Not Confirmed

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RLD :

TE Code :

Brand Name : AFATINIB

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG

Approval Date :

Application Number : 210804

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

MSN PHARMACEUTICALS INC

RDD

Not Confirmed

MSN PHARMACEUTICALS INC

RDD

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Digital Content

RLD :

TE Code :

Brand Name : AFATINIB

Dosage Form : TABLET;ORAL

Dosage Strength : 40MG

Approval Date :

Application Number : 210804

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

SANDOZ INC

RDD

Not Confirmed

SANDOZ INC

RDD

Not Confirmed

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Digital Content

RLD :

TE Code :

Brand Name : AFATINIB

Dosage Form : TABLET

Dosage Strength : 30MG

Approval Date :

Application Number : 210703

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

SANDOZ INC

RDD

Not Confirmed

SANDOZ INC

RDD

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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Digital Content

RLD :

TE Code :

Brand Name : AFATINIB

Dosage Form : TABLET

Dosage Strength : 20MG

Approval Date :

Application Number : 210703

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

SANDOZ INC

RDD

Not Confirmed

SANDOZ INC

RDD

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 :

TE Code :

Brand Name : AFATINIB

Dosage Form : TABLET

Dosage Strength : 40MG

Approval Date :

Application Number : 210703

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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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.