SAPROPTERIN Pharmacologic Class Indexing
- Class set ID
- 76e2c3c0-c817-4604-98fa-9f2589e2a18b
- Version
- 3
- Effective date
- 20180813
- Type
- Indexing - Pharmacologic Class
Mapped DailyMed Labels#
Label, Manufacturer, Effective table| Label | Manufacturer | Effective | SPL version |
|---|
| These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION . SAPROPTERIN DIHYDROCHLORIDE powder for oral solution Initial U.S. Approval: 2007 | Par Health USA, LLC | 20260428 | 24 |
| These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS . SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007 | Par Health USA, LLC | Par Formulations Private Limited | 20260417 | 15 |
| These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION. SAPROPTERIN DIHYDROCHLORIDE powder for oral solution Initial U.S. Approval: 2007 | Camber Pharmaceuticals, Inc. | Annora Pharma Private Limited | 20260305 | 3 |
| These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007 | Camber Pharmaceuticals, Inc. | Annora Pharma Private Limited | 20260224 | 3 |
| These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION. SAPROPTERIN DIHYDROCHLORIDE powder for oral solution Initial U.S. Approval: 2007 | TRUPHARMA, LLC | Mikart, LLC | 20260218 | 2 |
| These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION. SAPROPTERIN DIHYDROCHLORIDE powder, for oral solution Initial U.S. Approval: 2007 | Micro Labs Limited | 20260114 | 1 |
| These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007 | Hikma Pharmaceuticals USA Inc. | Zenara Pharma Private Limited | 20250731 | 2 |
| These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007 | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 20250610 | 1 |
| These highlights do not include all the information needed to use ZELVYSIA safely and effectively. See full prescribing information for ZELVYSIA. ZELVYSIA TM (sapropterin dihydrochloride) powder, for oral solution Initial U.S. Approval: 2007 | Aucta Pharmaceuticals, Inc. | 20250430 | 1 |
| These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007 | NorthStar RxLLC | Annora Pharma Private Limited | 20250106 | 3 |
| These highlights do not include all the information needed to use JAVYGTOR safely and effectively. See full prescribing information for JAVYGTOR. JAVYGTOR™ (sapropterin dihydrochloride) powder for oral solution. Initial U.S. Approval: 2007 | Dr. Reddys Laboratories Inc | 20241022 | 4 |
| These highlights do not include all the information needed to use JAVYGTOR safely and effectively. See full prescribing information for JAVYGTOR . JAVYGTOR TM (sapropterin dihydrochloride) powder for oral solution. Initial U.S. Approval: 2007 | Dr. Reddys Laboratories Inc | Dr. Reddys Laboratories Limited (SEZ UNIT) | 20241021 | 4 |
| These highlights do not include all the information needed to use JAVYGTOR safely and effectively. See full prescribing information for JAVYGTOR. JAVYGTOR TM (sapropterin dihydrochloride) tablets, for oral use. Initial U.S. Approval: 2007 | Dr. Reddys Laboratories Inc | Dr. Reddys Laboratories Limited (SEZ UNIT) | 20241021 | 2 |
| These highlights do not include all the information needed to use KUVAN safely and effectively. See full prescribing information for KUVAN. KUVAN (sapropterin dihydrochloride) tablets, for oral use KUVAN (sapropterin dihydrochloride) powder, for oral solution Initial U.S. Approval: 2007 | BioMarin Pharmaceutical Inc. | Almac Pharma Services Limited | 20240826 | 79 |
| These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION. SAPROPTERIN DIHYDROCHLORIDE powder for oral solution Initial U.S. Approval: 2007 | NorthStar RxLLC | Annora Pharma Private Limited | 20240709 | 3 |
| These highlights do not include all the information needed to use S APROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION safely and effectively. See full prescribing information for S APROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION . SAPROPTERIN DIHYDROCHLORIDE powder for oral solution Initial U.S. Approval: 2007 | Par Health USA, LLC | 20200709 | 14 |