Details for New Drug Application (NDA): 217836
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NDA 217836 describes QLOSI, which is a drug marketed by Orasis Pharms and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the QLOSI profile page.
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.
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: | 10,639,297 | Patent Expiration: | Aug 18, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF PRESBYOPIA | ||||||||
| Patent: | 11,129,812 | Patent Expiration: | Aug 18, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PRESBYOPIA | ||||||||
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