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Serving leading biopharmaceutical companies globally:

Chubb
Farmers Insurance
Fish and Richardson
Cerilliant
Healthtrust
US Department of Justice
Dow
McKinsey
Johnson and Johnson
AstraZeneca

Generated: November 17, 2017

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:
1
Applicant:
1
Ingredient:
1
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)

Summary 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:

QuintilesIMS
Boehringer Ingelheim
US Army
Accenture
Fish and Richardson
Express Scripts
Mallinckrodt
Moodys
Chinese Patent Office
Queensland Health

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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