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Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020378

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NDA 020378 describes GONAL-F, which is a drug marketed by Emd Serono and is included in three NDAs. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the GONAL-F profile page.

The generic ingredient in GONAL-F 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 020378
Tradename:GONAL-F
Applicant:Emd Serono
Ingredient:follitropin alfa/beta
Patents:1
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020378
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378 NDA EMD Serono, Inc. 44087-9030 N 44087-9030-1
GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378 NDA EMD Serono, Inc. 44087-9070 N 44087-9070-1

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength75 IU/VIAL
Approval Date:Sep 29, 1997TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength150 IU/VIAL
Approval Date:Sep 29, 1997TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength37.5 IU/VIAL
Approval Date:May 25, 2000TE:RLD:No

Expired US Patents for NDA 020378

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-003 May 25, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-001 Sep 29, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-004 Feb 28, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-002 Sep 29, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-005 Mar 26, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-004 Feb 28, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-005 Mar 26, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-002 Sep 29, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-003 May 25, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-001 Sep 29, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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