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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Merck
Colorcon
US Department of Justice
Julphar
Baxter
Boehringer Ingelheim
Harvard Business School
Fuji

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021765

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NDA 021765 describes GONAL-F RFF, which is a drug marketed by Emd Serono and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the GONAL-F RFF profile page.

The generic ingredient in GONAL-F RFF is follitropin alfa/beta. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the follitropin alfa/beta profile page.
Summary for 021765
Tradename:GONAL-F RFF
Applicant:Emd Serono
Ingredient:follitropin alfa/beta
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021765
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021765 NDA EMD Serono, Inc. 44087-9005 N 44087-9005-6
GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021765 NDA EMD Serono, Inc. 44087-9005 N 44087-9005-1

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength37.5 IU/VIAL
Approval Date:Mar 25, 2004TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength75 IU/VIAL
Approval Date:Mar 25, 2004TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength150 IU/VIAL
Approval Date:Mar 25, 2004TE:RLD:No

Expired US Patents for NDA 021765

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono GONAL-F RFF follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021765-002 Mar 25, 2004 ➤ Sign Up ➤ Sign Up
Emd Serono GONAL-F RFF follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021765-002 Mar 25, 2004 ➤ Sign Up ➤ Sign Up
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021765-001 Mar 25, 2004 ➤ Sign Up ➤ Sign Up
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021765-003 Mar 25, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Deloitte
Dow
Teva
Covington
Queensland Health
Federal Trade Commission
Cipla
Chinese Patent Office

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