Details for New Drug Application (NDA): 213978
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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
Mechanism of Action | Cholinergic Agonists Partial Cholinergic Nicotinic Agonists |
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: | RX | Dosage: | SPRAY;NASAL | Strength | EQ 0.03MG BASE/SPRAY | ||||
Approval Date: | Oct 15, 2021 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Oct 15, 2024 | ||||||||
Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 19, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 19, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
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