Serostim
These highlights do not include all the information needed to use SEROSTIM safely and effectively. See full prescribing information for SEROSTIM. SEROSTIM (somatropin) for injection, for subcutaneous use Initial U.S. Approval: 1987
Approved
Approval ID
62b01d29-90f0-45b2-a0c4-3a750ba36c8a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 2, 2022
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 Code44087-0004
Application NumberBLA020604
Product Classification
M
Marketing Category
C73585
G
Generic Name
somatropin
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJune 1, 2019
FDA Product Classification
somatropin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44087-0006
Application NumberBLA020604
Product Classification
M
Marketing Category
C73585
G
Generic Name
somatropin
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJune 1, 2019
FDA Product Classification
somatropin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44087-0005
Application NumberBLA020604
Product Classification
M
Marketing Category
C73585
G
Generic Name
somatropin
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJune 1, 2019
FDA Product Classification