PHENTOLAMINE MESYLATE - Food and Drug Administration
- Set ID
- 52987bfd-5e19-a3f5-c33e-e68c5f75fe88
- Type
- Indexing - Product Concept
- Effective date
- 2017-08-15
- Version
- 2
- Source
- DailyMed source
Mapped DailyMed Labels#
Label, Relation, Manufacturer table| Label | Relation | Manufacturer | Effective |
|---|
| These highlights do not include all the information needed to use RYZUMVI safely and effectively. See full prescribing information for RYZUMVI. RYZUMVI ® (phentolamine ophthalmic solution), for topical ophthalmic use Initial U.S. Approval: 1952 | Product name | Oyster Point Pharma, Inc. | 2026-10-09 |
| These highlights do not include all the information needed to use RYZUMVI safely and effectively. See full prescribing information for RYZUMVI. RYZUMVI ® (phentolamine ophthalmic solution), for topical ophthalmic use Initial U.S. Approval: 1952 | Product name | Oyster Point Pharma, Inc. | 2026-03-15 |
| These highlights do not include all the information needed to use RYZUMVI safely and effectively. See full prescribing information for RYZUMVI. RYZUMVI ® (phentolamine ophthalmic solution), for topical ophthalmic use Initial U.S. Approval: 1952 | Product name | Oyster Point Pharma, Inc. | 2026-03-15 |
| These highlights do not include all the information needed to use RYZUMVI safely and effectively. See full prescribing information for RYZUMVI. RYZUMVI ® (phentolamine ophthalmic solution), for topical ophthalmic use Initial U.S. Approval: 1952 | Product name | Oyster Point Pharma, Inc. | 2026-03-15 |
| Phentolamine Mesylate for Injection USP, 5mg | Product name | Precision Dose Inc. | NerPharMa S.r.l | 2024-08-19 |
| These highlights do not include all the information needed to use RYZUMVI safely and effectively. See full prescribing information for RYZUMVI. RYZUMVI™ (phentolamine ophthalmic solution), for topical ophthalmic use Initial U.S. Approval: 1952 | Product name | Oyster Point Pharma, Inc. | 2024-05-31 |
| PHENTOLAMINE MESYLATE FOR INJECTION, USP | Product name | Hikma Pharmaceuticals USA Inc. | 2024-03-13 |
| Phentolamine Mesylate | Product name | BLUEBAY SHANDONG CO.,LTD | 2021-01-29 |
| These highlights do not include all the information needed to use OraVerse™ safely and effectively. See full prescribing information for OraVerse. OraVerse (phentolamine mesylate) Injection Initial U.S. Approval: 1952 | Product name | Septodont, Inc. | Novocol Pharmaceutical of Canada, Inc. | 2018-12-05 |
| AX Pharmaceutical Corp bulk ingredient | Product name | AX Pharmaceutical Corp | 2018-07-27 |
| AX Pharmaceutical Corp bulk ingredient | Product name | AX Pharmaceutical Corp | 2018-07-04 |
| Novalar Pharmaceuticals human prescription drug labeling with highlights | Product name | Novalar Pharmaceuticals | 2008-05-23 |