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Last Updated: October 7, 2024

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.
Summary for 217064
Tradename:RYZUMVI
Applicant:Famygen Life Sci
Ingredient:phentolamine mesylate
Patents:6
Pharmacology for NDA: 217064
Mechanism of ActionAdrenergic 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:RXDosage:SOLUTION;OPHTHALMICStrengthEQ 0.75% BASE
Approval Date:Sep 25, 2023TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 25, 2026
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Sign UpPatent Expiration:Jan 31, 2034Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jan 31, 2034Product Flag?YSubstance Flag?Delist Request?

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