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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 NDA: 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 44087-9030-1 1 KIT in 1 CARTON (44087-9030-1) * 1 mL in 1 VIAL * 1 mL in 1 SYRINGE
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS 020378 NDA EMD Serono, Inc. 44087-9070 44087-9070-1 1 KIT in 1 CARTON (44087-9070-1) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 020378

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS020378-004Feb 28, 20015,767,251► subscribe
Emd Serono
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS020378-005Mar 26, 20045,767,067► subscribe
Emd Serono
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS020378-005Mar 26, 20045,767,251► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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