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FDA BLA · BLA021597

ZORBTIVE

Sponsor: EMD SERONO

APPLICATION
BLA021597
TYPE
BLA
ORIGINAL APPROVAL
2003-12-01
LATEST ACTION
2003-12-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

ZORBTIVEDiscontinued
SOMATROPIN RECOMBINANT 5MG/VIAL · INJECTABLE · INJECTION
ZORBTIVEDiscontinued
SOMATROPIN RECOMBINANT 6MG/VIAL · INJECTABLE · INJECTION
ZORBTIVEDiscontinued
SOMATROPIN RECOMBINANT 4MG/VIAL · INJECTABLE · INJECTION
ZORBTIVEPrescription
SOMATROPIN RECOMBINANT 8.8MG/VIAL · INJECTABLE · INJECTION

Approval history

2003-12-01Type 6 - New Indication (no longer used) · Original · standard — Other ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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