Gonal-f RFF Redi-ject
These highlights do not include all the information needed to use Gonal-f RFF Redi-ject safely and effectively. See full prescribing information for Gonal-f RFF Redi-ject Gonal-f RFF* Redi-ject (follitropin alfa injection) for subcutaneous use *revised formulation female Initial U.S. Approval: 1997
Approved
Approval ID
b6d11c45-b502-478e-bb28-2ff596ea259c
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.
FOLLITROPIN
PRODUCT DETAILS
NDC Product Code44087-1117
Application NumberBLA021684
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 19, 2020
Generic NameFOLLITROPIN
INGREDIENTS (7)
FOLLITROPINActive
Quantity: 900 [iU] in 1.5 mL
Code: 076WHW89TW
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
METHIONINEInactive
Code: AE28F7PNPL
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
FOLLITROPIN
PRODUCT DETAILS
NDC Product Code44087-1116
Application NumberBLA021684
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 19, 2020
Generic NameFOLLITROPIN
INGREDIENTS (7)
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT
METHIONINEInactive
Code: AE28F7PNPL
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
FOLLITROPINActive
Quantity: 450 [iU] in 0.75 mL
Code: 076WHW89TW
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FOLLITROPIN
PRODUCT DETAILS
NDC Product Code44087-1115
Application NumberBLA021684
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 19, 2020
Generic NameFOLLITROPIN
INGREDIENTS (7)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
FOLLITROPINActive
Quantity: 300 [iU] in 0.5 mL
Code: 076WHW89TW
Classification: ACTIB
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT
METHIONINEInactive
Code: AE28F7PNPL
Classification: IACT