Active ingredient
Follicle Stimulating Hormone
6 finished FDA listings contain Follicle Stimulating Hormone as their only active ingredient; 3 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- FOLLITROPIN
- Dosage forms
- Injection, Solution
- Routes
- Subcutaneous
- Manufacturers / labelers
- 2
- Strengths listed
- 300 [iu]/.36ml · 300 [iu]/.5ml · 450 [iu]/.75ml · 600 [iu]/.72ml · 900 [iu]/1.08ml · 900 [iu]/1.5ml
- Brand names in FDA listings
- Follistim Aq, Gonal-F Rff Redi-Ject
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 227518
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| BLA 021211 | ORGANON USA LLC | 2004-03-23 | 3 |
| BLA 021684 | EMD SERONO | 2004-05-25 | 3 |
Official labeling on DailyMed
- FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON LLC ] · version 11 · 2026-05-28
- GONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.] · version 13 · 2025-04-07
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.