Quick answers
- What is Follistim AQ?
- Follistim AQ is a brand name of Follitropin, a prescription medicine. The FDA NDC Directory lists 3 Follistim AQ products in 3 strengths and forms.
- Who makes Follistim AQ?
- Organon USA LLC holds the FDA application for Follistim AQ (BLA021211, approved March 23, 2004).
- Is there a generic or store brand of Follistim AQ?
- Other products of Follitropin are listed with the FDA, but none in exactly the same strength and form as a Follistim AQ product.
- Has Follistim AQ been recalled?
- No recall linked to Follistim AQ products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Follistim AQ is
Each Follistim AQ product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Follitropin · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| follitropin 300 units/0.36 mL injection, solution (subcutaneous) | Follistim AQ | None listed | DailyMed |
| follitropin 600 units/0.72 mL injection, solution (subcutaneous) | Follistim AQ | None listed | DailyMed |
| follitropin 900 units/1.08 mL injection, solution (subcutaneous) | Follistim AQ | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Follitropin →
FDA approval
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| BLA021211 | Organon USA LLC | March 23, 2004 | 3 |
Companies that list Follistim AQ
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Follistim AQ products.
- Organon LLC3 products
Recalls
No recall linked to Follistim AQ products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.