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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

NDC Product Code44087-0004
Application NumberBLA020604
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateJune 1, 2019
Generic Namesomatropin

somatropin

PRODUCT DETAILS

NDC Product Code44087-0006
Application NumberBLA020604
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateJune 1, 2019
Generic Namesomatropin

somatropin

PRODUCT DETAILS

NDC Product Code44087-0005
Application NumberBLA020604
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateJune 1, 2019
Generic Namesomatropin

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