Saizen
These highlights do not include all the information needed to use SAIZEN safely and effectively. See full prescribing information for SAIZEN. SAIZEN (somatropin) for injection, for subcutaneous use Initial U.S. Approval: 1987
Approved
Approval ID
ab750de2-3eda-411a-924e-00c499eda39b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 19, 2023
Manufacturers
FDA
EMD Serono, Inc.
DUNS: 088514898
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
somatropin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44087-1005
Application NumberBLA019764
Product Classification
M
Marketing Category
C73585
G
Generic Name
somatropin
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAMUSCULAR
Effective DateFebruary 12, 2020
FDA Product Classification
somatropin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44087-1088
Application NumberBLA019764
Product Classification
M
Marketing Category
C73585
G
Generic Name
somatropin
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAMUSCULAR
Effective DateFebruary 12, 2020
FDA Product Classification
somatropin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44087-0016
Application NumberBLA019764
Product Classification
M
Marketing Category
C73585
G
Generic Name
somatropin
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAMUSCULAR
Effective DateFebruary 12, 2020
FDA Product Classification