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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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code44087-1117
Application NumberBLA021684
Product Classification
M
Marketing Category
C73585
G
Generic Name
FOLLITROPIN
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 19, 2020
FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code44087-1116
Application NumberBLA021684
Product Classification
M
Marketing Category
C73585
G
Generic Name
FOLLITROPIN
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 19, 2020
FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code44087-1115
Application NumberBLA021684
Product Classification
M
Marketing Category
C73585
G
Generic Name
FOLLITROPIN
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 19, 2020
FDA Product Classification

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

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Gonal-f RFF Redi-ject - FDA Drug Approval Details