Details for New Drug Application (NDA): 217836
✉ Email this page to a colleague
The generic ingredient in QLOSI is pilocarpine hydrochloride. There are twelve drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the pilocarpine hydrochloride profile page.
Summary for 217836
Tradename: | QLOSI |
Applicant: | Orasis Pharms |
Ingredient: | pilocarpine hydrochloride |
Patents: | 4 |
Pharmacology for NDA: 217836
Mechanism of Action | Cholinergic Agonists Cholinergic Muscarinic Agonists |
Suppliers and Packaging for NDA: 217836
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
QLOSI | pilocarpine hydrochloride | SOLUTION;OPHTHALMIC | 217836 | NDA | Orasis Pharmaceuticals, Inc. | 83661-018 | 83661-018-30 | 30 VIAL, SINGLE-USE in 1 BOX (83661-018-30) / .4 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;OPHTHALMIC | Strength | 0.4% | ||||
Approval Date: | Oct 17, 2023 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Oct 17, 2026 | ||||||||
Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 18, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF PRESBYOPIA | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 18, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF PRESBYOPIA |
Complete Access Available with Subscription