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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 213978


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NDA 213978 describes TYRVAYA, which is a drug marketed by Oyster Point Pharma 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 TYRVAYA profile page.

The generic ingredient in TYRVAYA is varenicline tartrate. There are twelve drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.
Summary for 213978
Tradename:TYRVAYA
Applicant:Oyster Point Pharma
Ingredient:varenicline tartrate
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 213978
Medical Subject Heading (MeSH) Categories for 213978
Suppliers and Packaging for NDA: 213978
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TYRVAYA varenicline tartrate SPRAY;NASAL 213978 NDA Oyster Point Pharma 73521-030 73521-030-02 2 BOTTLE, PUMP in 1 CARTON (73521-030-02) / 4.2 mL in 1 BOTTLE, PUMP
TYRVAYA varenicline tartrate SPRAY;NASAL 213978 NDA Oyster Point Pharma 73521-030 73521-030-90 1 BOTTLE, PUMP in 1 CARTON (73521-030-90) / 4.2 mL in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;NASALStrengthEQ 0.03MG BASE/SPRAY
Approval Date:Oct 15, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 15, 2024
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Try a TrialPatent Expiration:Oct 19, 2035Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
Patent:⤷  Try a TrialPatent Expiration:Oct 19, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

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