| 0054-0906 | sapropterin dihydrochloride | sapropterin dihydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA |
| 31722-045 | sapropterin dihydrochloride | sapropterin dihydrochloride | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-047 | Sapropterin dihydrochloride | Sapropterin dihydrochloride | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-048 | Sapropterin dihydrochloride | Sapropterin dihydrochloride | Camber Pharmaceuticals, Inc. | ANDA |
| 42571-509 | Sapropterin Dihydrochloride | Sapropterin Dihydrochloride | Micro Labs Limited | ANDA |
| 42571-510 | Sapropterin Dihydrochloride | Sapropterin Dihydrochloride | Micro Labs Limited | ANDA |
| 43598-096 | JAVYGTOR | Sapropterin Dihydrochloride | Dr. Reddys Laboratories Inc | ANDA |
| 43598-097 | JAVYGTOR | Sapropterin Dihydrochloride | Dr. Reddys Laboratories Inc | ANDA |
| 43598-162 | JAVYGTOR | Sapropterin Dihydrochloride | Dr. Reddys Laboratories Inc | ANDA |
| 49884-720 | sapropterin dihydrochloride | sapropterin dihydrochloride | Par Health USA, LLC | ANDA |
| 49884-873 | SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE | Par Health USA, LLC | ANDA |
| 49884-948 | SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE | Par Health USA, LLC | ANDA |
| 52817-850 | Sapropterin Dihydrochloride | Sapropterin Dihydrochloride | TRUPHARMA, LLC | ANDA |
| 52817-851 | Sapropterin Dihydrochloride | Sapropterin Dihydrochloride | TRUPHARMA, LLC | ANDA |
| 59651-574 | Sapropterin Dihydrochloride | Sapropterin Dihydrochloride | Aurobindo Pharma Limited | ANDA |
| 68135-300 | Kuvan | SAPROPTERIN DIHYDROCHLORIDE | BioMarin Pharmaceutical Inc. | NDA |
| 68135-301 | Kuvan | SAPROPTERIN DIHYDROCHLORIDE | BioMarin Pharmaceutical Inc. | NDA |
| 68135-482 | Kuvan | sapropterin dihydrochloride | BioMarin Pharmaceutical Inc. | NDA |
| 72603-191 | sapropterin dihydrochloride | sapropterin dihydrochloride | NorthStar RxLLC | ANDA |
| 72603-193 | Sapropterin dihydrochloride | Sapropterin dihydrochloride | NorthStar RxLLC | ANDA |
| 72603-194 | Sapropterin dihydrochloride | Sapropterin dihydrochloride | NorthStar RxLLC | ANDA |
| 73289-0070 | ZELVYSIA | SAPROPTERIN DIHYDROCHLORIDE | Aucta Pharmaceuticals, Inc. | ANDA |
| 73289-0071 | ZELVYSIA | sapropterin dihydrochloride | Aucta Pharmaceuticals, Inc. | ANDA |
| 43598-477 | Sapropterin Dihydrochloride | Sapropterin Dihydrochloride | Dr. Reddys Laboratories Inc | ANDA |
| 43598-749 | Sapropterin Dihydrochloride | Sapropterin Dihydrochloride | Dr. Reddys Laboratories Inc. | NDA |