FDA.reportPublic FDA data

Application 018983

Type
NDA
Sponsor
MYLAN SPECIALITY LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
004COLYTEPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUSFOR SOLUTION;ORAL227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKETNoNo
005COLYTEPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUSFOR SOLUTION;ORAL120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKETNoNo
006COLYTEPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUSFOR SOLUTION;ORAL360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKETNoNo
007COLYTEPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUSFOR SOLUTION;ORAL240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTNoNo
008COLYTE-FLAVOREDPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUSFOR SOLUTION;ORAL227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOTNoNo
009COLYTE-FLAVOREDPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUSFOR SOLUTION;ORAL240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTNoNo
010COLYTEPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUSFOR SOLUTION;ORAL227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOTNoNo
012COLYTE WITH FLAVOR PACKSPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUSFOR SOLUTION;ORAL240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018983-004COLYTEPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS227.1GM/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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD1984-10-26
N018983-005COLYTEPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS120GM/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 / ORALRLD1984-10-26
N018983-006COLYTEPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS360GM/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 / ORALRLD1984-10-26
N018983-007COLYTEPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS240GM/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 / ORALRLD1987-06-12
N018983-008COLYTE-FLAVOREDPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS227.1GM/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 / ORALRLD1991-11-14
N018983-009COLYTE-FLAVOREDPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS240GM/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 / ORALRLD1991-11-14
N018983-010COLYTEPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS227.1GM/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 / ORALRLD1989-01-31
N018983-012COLYTE WITH FLAVOR PACKSPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALRLD1998-10-08

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.

Product history page 1 of 9 · 328 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N018983-004COLYTE227.1GM/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 / ORAL1984-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018983-005COLYTE120GM/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 / ORAL1984-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018983-006COLYTE360GM/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 / ORAL1984-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018983-007COLYTE240GM/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 / ORAL1987-06-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018983-008COLYTE-FLAVORED227.1GM/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 / ORAL1991-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018983-009COLYTE-FLAVORED240GM/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 / ORAL1991-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018983-010COLYTE227.1GM/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 / ORAL1989-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018983-012COLYTE WITH FLAVOR PACKS240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORAL1998-10-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018983-004COLYTE227.1GM/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 / ORAL1984-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018983-005COLYTE120GM/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 / ORAL1984-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018983-006COLYTE360GM/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 / ORAL1984-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018983-007COLYTE240GM/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 / ORAL1987-06-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018983-008COLYTE-FLAVORED227.1GM/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 / ORAL1991-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018983-009COLYTE-FLAVORED240GM/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 / ORAL1991-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018983-010COLYTE227.1GM/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 / ORAL1989-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018983-012COLYTE WITH FLAVOR PACKS240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORAL1998-10-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N018983-004COLYTE227.1GM/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 / ORAL1984-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018983-005COLYTE120GM/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 / ORAL1984-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018983-006COLYTE360GM/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 / ORAL1984-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018983-007COLYTE240GM/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 / ORAL1987-06-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018983-008COLYTE-FLAVORED227.1GM/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 / ORAL1991-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018983-009COLYTE-FLAVORED240GM/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 / ORAL1991-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018983-010COLYTE227.1GM/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 / ORAL1989-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018983-012COLYTE WITH FLAVOR PACKS240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORAL1998-10-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018983-004COLYTE227.1GM/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 / ORAL1984-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018983-005COLYTE120GM/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 / ORAL1984-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018983-006COLYTE360GM/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 / ORAL1984-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018983-007COLYTE240GM/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 / ORAL1987-06-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018983-008COLYTE-FLAVORED227.1GM/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 / ORAL1991-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018983-009COLYTE-FLAVORED240GM/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 / ORAL1991-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018983-010COLYTE227.1GM/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 / ORAL1989-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018983-012COLYTE WITH FLAVOR PACKS240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORAL1998-10-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018983-004COLYTE227.1GM/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 / ORAL1984-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018983-005COLYTE120GM/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 / ORAL1984-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018983-006COLYTE360GM/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 / ORAL1984-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018983-007COLYTE240GM/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 / ORAL1987-06-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018983-008COLYTE-FLAVORED227.1GM/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 / ORAL1991-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018983-009COLYTE-FLAVORED240GM/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 / ORAL1991-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018983-010COLYTE227.1GM/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 / ORAL1989-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018983-012COLYTE WITH FLAVOR PACKS240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORAL1998-10-08b8a1b40f171c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018983-012AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018983-012AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018983-012AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018983-012AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018983-012AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018983-012AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018983-012AA187673890dc5c…
2021-03-12 10:30 UTC2021-03N018983-012AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018983-012AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018983-012AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018983-012AA13f01610625f2…
2019-09-15 20:21 UTC2019-09N018983-012AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018983-012AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018983-012AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018983-012AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018983-012AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018983-012AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018983-012AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018983-012AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018983-012AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018983-012AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018983-012AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018983-012AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018983-012AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018983-012AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018983-012AA1cb3db0bc1861…

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0037-6820COLYTEpeg-3350 and electrolytesMeda PharmaceuticalsNDACurrent
0037-6820COLYTEpeg-3350 and electrolytesMeda PharmaceuticalsNDACurrent
0037-6820COLYTEpeg-3350 and electrolytesMeda PharmaceuticalsNDACurrent
62175-446PEG-3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE, and SODIUM SULFATELannett Company, Inc..NDA AUTHORIZED GENERICCurrent
62175-446PEG-3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE, and SODIUM SULFATELannett Company, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67523SUPPL2021-05-18
67492SUPPL2021-05-17
16155SUPPL2013-08-22
33678SUPPL2013-08-19
1177SUPPL2003-11-25
1176SUPPL2002-09-16