Details for New Drug Application (NDA): 217064
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NDA 217064 describes RYZUMVI, which is a drug marketed by Famygen Life Sci and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the RYZUMVI profile page.
The generic ingredient in RYZUMVI is phentolamine mesylate. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the phentolamine mesylate profile page.
The generic ingredient in RYZUMVI is phentolamine mesylate. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the phentolamine mesylate profile page.
Summary for 217064
| Tradename: | RYZUMVI |
| Applicant: | Famygen Life Sci |
| Ingredient: | phentolamine mesylate |
| Patents: | 6 |
Pharmacology for NDA: 217064
| Mechanism of Action | Adrenergic alpha-Antagonists |
Medical Subject Heading (MeSH) Categories for 217064
Suppliers and Packaging for NDA: 217064
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RYZUMVI | phentolamine mesylate | SOLUTION;OPHTHALMIC | 217064 | NDA | Oyster Point Pharma, Inc. | 83368-075 | 83368-075-30 | 6 POUCH in 1 CARTON (83368-075-30) / 5 VIAL, SINGLE-USE in 1 POUCH / 1 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;OPHTHALMIC | Strength | EQ 0.75% BASE | ||||
| Approval Date: | Sep 25, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 25, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 31, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 31, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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