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Serving leading biopharmaceutical companies globally:

Novartis
Argus Health
Covington
Johnson and Johnson
Cipla
Julphar
Harvard Business School
Dow
QuintilesIMS
Chinese Patent Office

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021663

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NDA 021663 describes MENOPUR, which is a drug marketed by Ferring and is included in one NDA. It is available from one supplier. Additional details are available on the MENOPUR profile page.

The generic ingredient in MENOPUR is menotropins (fsh;lh). There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the menotropins (fsh;lh) profile page.
Summary for 021663
Tradename:MENOPUR
Applicant:Ferring
Ingredient:menotropins (fsh;lh)
Patents:0
Suppliers and Packaging for NDA: 021663
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MENOPUR menotropins (fsh;lh) INJECTABLE;SUBCUTANEOUS 021663 NDA Ferring Pharmaceuticals Inc. 55566-7501 55566-7501-2 1 CARTON in 1 CARTON (55566-7501-2) > 1 KIT in 1 CARTON (55566-7501-1) * 1 mL in 1 VIAL (55566-7502-0) * 2 mL in 1 VIAL (0641-0495-17)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength75 IU/VIAL;75 IU/VIAL
Approval Date:Oct 29, 2004TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 19, 2017
Regulatory Exclusivity Use:ADDITIONAL INFORMATION ADDED TO THE DOSING AND ADMINISTRATION SECTION OF THE LABELING REGARDING THE ADMINISTRATION OF BRAVELLE AND MENOPUR IN THE SAME SYRINGE TO OVULATORY WOMEN AS PART OF AN ART CYCLE

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Serving leading biopharmaceutical companies globally:

Queensland Health
Teva
Merck
UBS
US Department of Justice
Boehringer Ingelheim
Fish and Richardson
Dow
Farmers Insurance

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