Application 018983
- Type
- NDA
- Sponsor
- MYLAN SPECIALITY LP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 004 | COLYTE | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | FOR SOLUTION;ORAL | 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET | No | No |
| 005 | COLYTE | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | FOR SOLUTION;ORAL | 120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET | No | No |
| 006 | COLYTE | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | FOR SOLUTION;ORAL | 360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET | No | No |
| 007 | COLYTE | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | FOR SOLUTION;ORAL | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | No | No |
| 008 | COLYTE-FLAVORED | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | FOR SOLUTION;ORAL | 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT | No | No |
| 009 | COLYTE-FLAVORED | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | FOR SOLUTION;ORAL | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | No | No |
| 010 | COLYTE | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | FOR SOLUTION;ORAL | 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT | No | No |
| 012 | COLYTE WITH FLAVOR PACKS | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | FOR SOLUTION;ORAL | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018983-004 | COLYTE | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 1984-10-26 | |
| N018983-005 | COLYTE | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | 120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 1984-10-26 | |
| N018983-006 | COLYTE | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | 360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 1984-10-26 | |
| N018983-007 | COLYTE | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 1987-06-12 | |
| N018983-008 | COLYTE-FLAVORED | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 1991-11-14 | |
| N018983-009 | COLYTE-FLAVORED | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 1991-11-14 | |
| N018983-010 | COLYTE | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 1989-01-31 | |
| N018983-012 | COLYTE WITH FLAVOR PACKS | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | FOR SOLUTION / ORAL | RLD | 1998-10-08 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018983-004 | COLYTE | 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | 1984-10-26 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018983-005 | COLYTE | 120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | 1984-10-26 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018983-006 | COLYTE | 360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | 1984-10-26 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018983-007 | COLYTE | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | 1987-06-12 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018983-008 | COLYTE-FLAVORED | 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | 1991-11-14 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018983-009 | COLYTE-FLAVORED | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | 1991-11-14 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018983-010 | COLYTE | 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | 1989-01-31 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018983-012 | COLYTE WITH FLAVOR PACKS | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | FOR SOLUTION / ORAL | 1998-10-08 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N018983-004 | COLYTE | 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | 1984-10-26 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N018983-005 | COLYTE | 120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | 1984-10-26 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N018983-006 | COLYTE | 360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | 1984-10-26 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N018983-007 | COLYTE | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | 1987-06-12 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N018983-008 | COLYTE-FLAVORED | 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | 1991-11-14 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N018983-009 | COLYTE-FLAVORED | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | 1991-11-14 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N018983-010 | COLYTE | 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | 1989-01-31 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N018983-012 | COLYTE WITH FLAVOR PACKS | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | FOR SOLUTION / ORAL | 1998-10-08 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018983-004 | COLYTE | 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET | FOR SOLUTION / ORAL | 1984-10-26 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018983-005 | COLYTE | 120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET | FOR SOLUTION / ORAL | 1984-10-26 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018983-006 | COLYTE | 360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET | FOR SOLUTION / ORAL | 1984-10-26 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018983-007 | COLYTE | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | FOR SOLUTION / ORAL | 1987-06-12 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018983-008 | COLYTE-FLAVORED | 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT | FOR SOLUTION / ORAL | 1991-11-14 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018983-009 | COLYTE-FLAVORED | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | FOR SOLUTION / ORAL | 1991-11-14 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018983-010 | COLYTE | 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT | FOR SOLUTION / ORAL | 1989-01-31 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018983-012 | COLYTE WITH FLAVOR PACKS | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | FOR SOLUTION / ORAL | AA | 1998-10-08 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018983-004 | COLYTE | 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET | FOR SOLUTION / ORAL | 1984-10-26 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N018983-005 | COLYTE | 120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET | FOR SOLUTION / ORAL | 1984-10-26 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N018983-006 | COLYTE | 360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET | FOR SOLUTION / ORAL | 1984-10-26 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N018983-007 | COLYTE | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | FOR SOLUTION / ORAL | 1987-06-12 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N018983-008 | COLYTE-FLAVORED | 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT | FOR SOLUTION / ORAL | 1991-11-14 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N018983-009 | COLYTE-FLAVORED | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | FOR SOLUTION / ORAL | 1991-11-14 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N018983-010 | COLYTE | 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT | FOR SOLUTION / ORAL | 1989-01-31 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N018983-012 | COLYTE WITH FLAVOR PACKS | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | FOR SOLUTION / ORAL | AA | 1998-10-08 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018983-004 | COLYTE | 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET | FOR SOLUTION / ORAL | 1984-10-26 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N018983-005 | COLYTE | 120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET | FOR SOLUTION / ORAL | 1984-10-26 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N018983-006 | COLYTE | 360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET | FOR SOLUTION / ORAL | 1984-10-26 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N018983-007 | COLYTE | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | FOR SOLUTION / ORAL | 1987-06-12 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N018983-008 | COLYTE-FLAVORED | 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT | FOR SOLUTION / ORAL | 1991-11-14 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N018983-009 | COLYTE-FLAVORED | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | FOR SOLUTION / ORAL | 1991-11-14 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N018983-010 | COLYTE | 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT | FOR SOLUTION / ORAL | 1989-01-31 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N018983-012 | COLYTE WITH FLAVOR PACKS | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | FOR SOLUTION / ORAL | AA | 1998-10-08 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018983-012 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N018983-012 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N018983-012 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N018983-012 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N018983-012 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N018983-012 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018983-012 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N018983-012 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N018983-012 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N018983-012 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N018983-012 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N018983-012 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N018983-012 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018983-012 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N018983-012 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N018983-012 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N018983-012 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N018983-012 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N018983-012 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N018983-012 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N018983-012 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N018983-012 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N018983-012 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N018983-012 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N018983-012 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N018983-012 | AA | 1 | cb3db0bc1861… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0037-6820 | COLYTE | peg-3350 and electrolytes | Meda Pharmaceuticals | NDA | Current |
| 0037-6820 | COLYTE | peg-3350 and electrolytes | Meda Pharmaceuticals | NDA | Current |
| 0037-6820 | COLYTE | peg-3350 and electrolytes | Meda Pharmaceuticals | NDA | Current |
| 62175-446 | PEG-3350 and Electrolytes | POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE, and SODIUM SULFATE | Lannett Company, Inc.. | NDA AUTHORIZED GENERIC | Current |
| 62175-446 | PEG-3350 and Electrolytes | POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE, and SODIUM SULFATE | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | Current |