Active ingredient
Sapropterin
23 finished FDA listings contain Sapropterin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SAPROPTERIN DIHYDROCHLORIDE
- Dosage forms
- Powder, For Solution, Tablet
- Routes
- Oral
- Manufacturers / labelers
- 10
- Strengths listed
- 100 mg/1 · 500 mg/1
- Brand names in FDA listings
- Javygtor, Kuvan, Zelvysia
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 753340
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 |
|---|---|---|---|
| NDA 022181 | BIOMARIN PHARM | 2007-12-13 | 1 |
| NDA 205065 | BIOMARIN PHARM | 2013-12-19 | 2 |
| ANDA 207200 | PH HEALTH | 2019-05-10 | 1 |
| ANDA 210027 | PH HEALTH | 2019-08-20 | 1 |
| ANDA 207207 | PH HEALTH | 2019-08-20 | 1 |
| ANDA 209452 | DR REDDYS | 2021-03-30 | 1 |
| ANDA 207685 | DR REDDYS | 2021-06-15 | 1 |
| ANDA 215798 | DR REDDYS | 2022-05-13 | 1 |
| ANDA 215420 | ANNORA PHARMA | 2022-08-18 | 4 |
| ANDA 215534 | ANNORA PHARMA | 2022-08-23 | 2 |
| ANDA 218645 | AUCTA | 2025-04-29 | 2 |
| ANDA 216797 | AUROBINDO PHARMA | 2025-06-09 | 1 |
| ANDA 218797 | HIKMA | 2025-06-11 | 1 |
| ANDA 216432 | TP ANDA HOLDINGS | 2025-09-03 | 2 |
| ANDA 219511 | MICRO LABS | 2026-01-08 | 2 |
Official labeling on DailyMed
- SAPROPTERIN DIHYDROCHLORIDE TABLET [HIKMA PHARMACEUTICALS USA INC.] · version 3 · 2026-08-07
- SAPROPTERIN DIHYDROCHLORIDE POWDER, FOR SOLUTION [PAR HEALTH USA, LLC] · version 24 · 2026-05-15
- SAPROPTERIN DIHYDROCHLORIDE POWDER, FOR SOLUTION [PAR HEALTH USA, LLC] · version 14 · 2026-05-15
- SAPROPTERIN DIHYDROCHLORIDE TABLET [PAR HEALTH USA, LLC] · version 15 · 2026-04-28
- SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [MICRO LABS LIMITED] · version 1 · 2026-04-02
- SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [CAMBER PHARMACEUTICALS, INC.] · version 3 · 2026-03-06
- SAPROPTERIN DIHYDROCHLORIDE (SAPROPTERIN DIHYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.] · version 3 · 2026-02-26
- SAPROPTERIN DIHYDROCHLORIDE POWDER, FOR SOLUTION [TRUPHARMA, LLC] · version 2 · 2026-02-19
- KUVAN (SAPROPTERIN DIHYDROCHLORIDE) TABLET KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION KUVAN (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [BIOMARIN PHARMACEUTICAL INC.] · version 79 · 2025-11-26
- SAPROPTERIN DIHYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED] · version 1 · 2025-06-17
- ZELVYSIA (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION ZELVYSIA (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [AUCTA PHARMACEUTICALS, INC.] · version 1 · 2025-05-02
- JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE) POWDER, FOR SOLUTION [DR. REDDYS LABORATORIES INC] · version 4 · 2025-01-23
Showing the 12 most recent of 16 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.