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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. There is one patent protecting this drug. 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. Eight suppliers are listed for this compound. Additional details are available on the somatropin recombinant profile page.

Summary for NDA: 021597

Tradename:
ZORBTIVE
Applicant:
Emd Serono
Ingredient:
somatropin recombinant
Patents:1
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) * 1 mL in 1 VIAL, GLASS * 3.5 mL in 1 VIAL, GLASS

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 021597

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono
ZORBTIVE
somatropin recombinant
INJECTABLE;INJECTION021597-004Dec 1, 20035,288,703► subscribe
Emd Serono
ZORBTIVE
somatropin recombinant
INJECTABLE;INJECTION021597-004Dec 1, 20035,898,030► subscribe
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