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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021597

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NDA 021597 describes ZORBTIVE, 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 ZORBTIVE profile page.

The generic ingredient in ZORBTIVE is somatropin recombinant. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the somatropin recombinant profile page.
Summary for 021597
Tradename:ZORBTIVE
Applicant:Emd Serono
Ingredient:somatropin recombinant
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021597
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZORBTIVE somatropin recombinant INJECTABLE;INJECTION 021597 NDA EMD Serono, Inc. 44087-3388 44087-3388-7 1 KIT in 1 CARTON (44087-3388-7) * 3.5 mL in 1 VIAL, GLASS * 1 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength4MG/VIAL
Approval Date:Dec 1, 2003TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength5MG/VIAL
Approval Date:Dec 1, 2003TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength6MG/VIAL
Approval Date:Dec 1, 2003TE:RLD:No

Expired US Patents for NDA 021597

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono ZORBTIVE somatropin recombinant INJECTABLE;INJECTION 021597-004 Dec 1, 2003   Start Trial   Start Trial
Emd Serono ZORBTIVE somatropin recombinant INJECTABLE;INJECTION 021597-004 Dec 1, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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