General MedicationsSUBCUTANEOUSStandard
GONAL-F RFF REDI-JECT
FOLLITROPIN ALFA/BETA
Standard Dose
900 IU/1.5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview GONAL-F RFF REDI-JECT is listed in Drugs@FDA under application 021684 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient FOLLITROPIN ALFA/BETA Form and strength INJECTABLE;SUBCUTANEOUS - 900 IU/1.5ML Sponsor EMD SERONO Submission history Latest submission status date: 2024-05-13 00:00:00.
Structured Monograph
Clinical summary
Approval overview GONAL-F RFF REDI-JECT is listed in Drugs@FDA under application 021684 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient FOLLITROPIN ALFA/BETA Form and strength INJECTABLE;SUBCUTANEOUS - 900 IU/1.5ML Sponsor EMD SERONO Submission history Latest submission status date: 2024-05-13 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.