Quick answers
- What is Javygtor?
- Javygtor is a brand name of Sapropterin dihydrochloride, a prescription medicine. The FDA NDC Directory lists 3 Javygtor products in 3 strengths and forms.
- Who makes Javygtor?
- Dr Reddys holds the FDA application for Javygtor (ANDA209452, approved March 30, 2021).
- Is there a generic or store brand of Javygtor?
- Yes. The FDA NDC Directory lists 20 other products with the same active ingredients, strength and form as a Javygtor product, 17 of them generic. Ask your pharmacist whether one is right for you.
- Has Javygtor been recalled?
- FDA enforcement reports list 2 recalls of Javygtor products; the newest started November 22, 2024. A recall usually concerns specific lots, not every product.
What Javygtor is
Each Javygtor 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.
Sapropterin dihydrochloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| sapropterin dihydrochloride 100 mg powder, for solution (oral) | Javygtor | 7 products, 7 companies | DailyMed |
| sapropterin dihydrochloride 100 mg tablet (oral) | Javygtor | 6 products, 6 companies | DailyMed |
| sapropterin dihydrochloride 500 mg powder, for solution (oral) | Javygtor | 7 products, 7 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Sapropterin dihydrochloride →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA209452 | Dr Reddys | March 30, 2021 | 1 |
| ANDA207685 | Dr Reddys | June 15, 2021 | 1 |
| ANDA215798 | Dr Reddys | May 13, 2022 | 1 |
Companies that list Javygtor
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Javygtor products.
- Dr. Reddys Laboratories Inc3 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
November 22, 2024 · Class III · Ongoing · D-0117-2025
Failed Impurities/Degradation Specifications
Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04. — Dr. Reddy's Laboratories, Inc.
-
April 8, 2024 · Class I · Ongoing · D-0485-2024
Sub-potent Drug; powder discoloration associated with decreased potency
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30. — Dr. Reddy's Laboratories, Inc.
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.