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. There are three 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. Fourteen 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. Fourteen 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: | 3 |
| Formulation / Manufacturing: | see details |
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: | ⤷ Try a Trial | Patent Expiration: | Aug 18, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF PRESBYOPIA | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 18, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PRESBYOPIA | ||||||||
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