Home Applications 217836 Application 217836
Type NDA
Sponsor ORASIS PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 QLOSI PILOCARPINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 0.4% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217836-001 QLOSI PILOCARPINE HYDROCHLORIDE 0.4% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-10-17
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217836-001 NP 2026-10-17
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N217836-001 QLOSI 0.4% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-10-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217836-001 QLOSI 0.4% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-10-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217836-001 QLOSI 0.4% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-10-17 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 66 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14 d06236e962d9…
Observed Orange Book exclusivity history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Qlosi PILOCARPINE HYDROCHLORIDE Orasis Pharmaceuticals, Inc. 4ee2a840-1203-473a-aa42-316a3ddf2fbe 2025-05-30 Warnings, Adverse reactions Exact identifier application applno (NDA): 217836 application number: NDA217836
Documents# Document, Submission type, Date table Document Submission type Date 78609 ORIG 2024-06-03 75884 ORIG 2023-10-20 75839 ORIG 2023-10-18