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Serving leading biopharmaceutical companies globally:

Fuji
Chubb
Julphar
Citi
Mallinckrodt
Chinese Patent Office
Fish and Richardson
Cipla
Merck
Moodys

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019764

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NDA 019764 describes SAIZEN, which is a drug marketed by Emd Serono and is included in one NDA. It is available from one supplier. Additional details are available on the SAIZEN profile page.

The generic ingredient in SAIZEN is somatropin recombinant. There are four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the somatropin recombinant profile page.
Summary for 019764
Tradename:SAIZEN
Applicant:Emd Serono
Ingredient:somatropin recombinant
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 019764
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SAIZEN somatropin recombinant INJECTABLE;INJECTION 019764 NDA EMD Serono, Inc. 44087-0016 44087-0016-1 1 KIT in 1 CARTON (44087-0016-1) * 1.51 mL in 1 VIAL, GLASS * 1.51 mL in 1 CARTRIDGE
SAIZEN somatropin recombinant INJECTABLE;INJECTION 019764 NDA EMD Serono, Inc. 44087-1005 44087-1005-2 1 KIT in 1 CARTON (44087-1005-2) * 3 mL in 1 VIAL, GLASS * 3.5 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength6MG/VIAL
Approval Date:Oct 8, 1996TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/VIAL
Approval Date:Oct 8, 1996TE:BXRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength8.8MG/VIAL
Approval Date:Aug 29, 2000TE:RLD:Yes

Expired US Patents for NDA 019764

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono SAIZEN somatropin recombinant INJECTABLE;INJECTION 019764-002 Oct 8, 1996 ➤ Subscribe ➤ Subscribe
Emd Serono SAIZEN somatropin recombinant INJECTABLE;INJECTION 019764-003 Aug 29, 2000 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Fuji
Johnson and Johnson
US Department of Justice
Covington
Queensland Health
QuintilesIMS
Daiichi Sankyo
Chubb
Merck

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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