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 ten 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. Twenty-four suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.
The generic ingredient in TYRVAYA is varenicline tartrate. There are twelve drug master file entries for this compound. Twenty-four 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: | 10 |
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: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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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