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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
AstraZeneca
Fish and Richardson
Chinese Patent Office
Federal Trade Commission
Dow
UBS
Cerilliant
Express Scripts
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Generated: November 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020604

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NDA 020604 describes SEROSTIM LQ, 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 SEROSTIM LQ profile page.

The generic ingredient in SEROSTIM LQ 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 020604

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020604

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SEROSTIM
somatropin recombinant
INJECTABLE;INJECTION 020604 NDA EMD Serono, Inc. 44087-0004 44087-0004-7 1 KIT in 1 CARTON (44087-0004-7) * 1 mL in 1 VIAL * 3.5 mL in 1 VIAL, GLASS
SEROSTIM
somatropin recombinant
INJECTABLE;INJECTION 020604 NDA EMD Serono, Inc. 44087-0005 44087-0005-7 1 KIT in 1 CARTON (44087-0005-7) * 1 mL in 1 VIAL * 1 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/VIAL
Approval Date:Aug 23, 1996TE:BXRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/VIAL
Approval Date:Aug 23, 1996TE:BXRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4MG/VIAL
Approval Date:Jul 25, 1997TE:BXRLD:No

Expired Orange Book Patents for NDA: 020604

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono
SEROSTIM
somatropin recombinant
INJECTABLE;INJECTION020604-001Aug 23, 1996► Subscribe► Subscribe
Emd Serono
SEROSTIM
somatropin recombinant
INJECTABLE;INJECTION020604-004Sep 6, 2001► Subscribe► Subscribe
Emd Serono
SEROSTIM
somatropin recombinant
INJECTABLE;INJECTION020604-003Jul 25, 1997► Subscribe► Subscribe
Emd Serono
SEROSTIM
somatropin recombinant
INJECTABLE;INJECTION020604-002Aug 23, 1996► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

AstraZeneca
UBS
McKesson
Baxter
Covington
Harvard Business School
QuintilesIMS
Chinese Patent Office
US Army
Federal Trade Commission

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