Application 018796
- Type
- NDA
- Sponsor
- ALCON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PILOPINE HS | PILOCARPINE HYDROCHLORIDE | GEL;OPHTHALMIC | 4% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018796-001 | PILOPINE HS | PILOCARPINE HYDROCHLORIDE | 4% | GEL / OPHTHALMIC | 1984-10-01 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N018796-001 | PILOPINE HS | 4% | GEL / OPHTHALMIC | 1984-10-01 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pilocarpine Hydrochloride | PILOCARPINE HYDROCHLORIDE | Amneal Pharmaceuticals NY LLC | 6272ccac-b543-404d-9938-8583bb59ed2c | 2026-04-15 | Warnings, Adverse reactions | PILOCARPINE HYDROCHLORIDE |
| Pilocarpine hydrochloride | PILOCARPINE HYDROCHLORIDE | American Health Packaging | 6f950741-fd3f-4bf7-83b0-f5aa9dbceb76 | 2026-01-23 | Warnings, Adverse reactions | PILOCARPINE HYDROCHLORIDE |
| Pilocarpine Hydrochloride | PILOCARPINE HYDROCHLORIDE | AvPAK | b85547d8-fcec-323d-e053-2995a90a4e7e | 2026-01-09 | Warnings, Adverse reactions | PILOCARPINE HYDROCHLORIDE |
| Pilocarpine Hydrochloride | PILOCARPINE HYDROCHLORIDE | Aurobindo Pharma Limited | 438cfaa3-b5f6-4d75-ac22-b0b4e07bb118 | 2025-10-03 | Warnings, Adverse reactions | PILOCARPINE HYDROCHLORIDE |
| Pilocarpine Hydrochloride Ophthalmic | PILOCARPINE HYDROCHLORIDE | Amneal Pharmaceuticals NY LLC | 93e37b61-7b90-4740-b0b4-17d39d3b03f6 | 2025-06-02 | Warnings, Adverse reactions | PILOCARPINE HYDROCHLORIDE |
| Qlosi | PILOCARPINE HYDROCHLORIDE | Orasis Pharmaceuticals, Inc. | 4ee2a840-1203-473a-aa42-316a3ddf2fbe | 2025-05-30 | Warnings, Adverse reactions | PILOCARPINE HYDROCHLORIDE |
| Pilocarpine Hydrochloride | PILOCARPINE HYDROCHLORIDE | Bryant Ranch Prepack | 06c054af-62b4-4373-813a-9bb2e5c92316 | 2024-12-12 | Warnings, Adverse reactions | PILOCARPINE HYDROCHLORIDE |
| Pilocarpine Hydrochloride | PILOCARPINE HYDROCHLORIDE | Bryant Ranch Prepack | fb97323d-acec-4e4a-af16-efef66d969dc | 2024-12-06 | Warnings, Adverse reactions | PILOCARPINE HYDROCHLORIDE |
| Salagen | PILOCARPINE HYDROCHLORIDE | Advanz Pharma (US) Corp. | 62eda83d-d043-4c7e-8fcf-75d05efbf35b | 2024-12-05 | Warnings, Adverse reactions | PILOCARPINE HYDROCHLORIDE |
| Pilocarpine Hydrochloride | PILOCARPINE HYDROCHLORIDE | Lannett Company, Inc. | 8db0db4f-55ad-46b2-af50-e71b4a763aaa | 2024-10-18 | Warnings, Adverse reactions | PILOCARPINE HYDROCHLORIDE |
| Pilocarpine Hydrochloride | PILOCARPINE HYDROCHLORIDE | Bryant Ranch Prepack | 6a73a702-c5e2-44ea-81c8-ee7e60852c41 | 2024-03-22 | Warnings, Adverse reactions | PILOCARPINE HYDROCHLORIDE |
| VUITY | PILOCARPINE HYDROCHLORIDE | AbbVie Inc. | 8d806897-8a2a-4518-8c68-0ec3b778de50 | 2023-03-28 | Warnings, Adverse reactions | PILOCARPINE HYDROCHLORIDE |
| Pilocarpine Hydrochloride | PILOCARPINE HYDROCHLORIDE | AMICI PHARMACEUTICALS LLC | a86a7b63-5f6a-4c10-9270-24c7b7d50437 | 2022-06-12 | Warnings, Adverse reactions | PILOCARPINE HYDROCHLORIDE |
| Pilocarpine hydrochloride | PILOCARPINE HYDROCHLORIDE | Actavis Pharma, Inc. | 610022b7-7dc9-405a-a580-104657f43bdf | 2021-08-31 | Warnings, Adverse reactions | PILOCARPINE HYDROCHLORIDE |
| Pilocarpine Hydrochloride | PILOCARPINE HYDROCHLORIDE | Amneal Pharmaceuticals NY LLC | 1e87a81a-7084-4436-918b-a50451534307 | 2021-01-03 | Warnings, Adverse reactions | PILOCARPINE HYDROCHLORIDE |
| Pilocarpine Hydrochloride | PILOCARPINE HYDROCHLORIDE | Sandoz Inc | 53fa0b7a-f982-48a7-92c4-6f098683c1ed | 2020-05-19 | Warnings, Adverse reactions | PILOCARPINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.