Home Applications 019797 Application 019797
Type NDA
Sponsor BRAINTREE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NULYTELY POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE FOR SOLUTION;ORAL 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT Yes Yes 002 NULYTELY-FLAVORED POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE FOR SOLUTION;ORAL 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019797-001 NULYTELY POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 N019797-002 NULYTELY-FLAVORED POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2 of 3 · 88 observed 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 2019-12-13 00:20 UTC 2019-12 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10572-302 PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride Affordable Pharmaceuticals, LLC NDA AUTHORIZED GENERIC Current 10572-302 PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride Affordable Pharmaceuticals, LLC NDA AUTHORIZED GENERIC Current 10572-302 PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride Affordable Pharmaceuticals, LLC NDA AUTHORIZED GENERIC Current 10572-400 PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride Affordable Pharmaceuticals, LLC NDA AUTHORIZED GENERIC Current 52268-302 NuLYTELY polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride Braintree Laboratories, Inc. NDA Current 52268-302 NuLYTELY polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride Braintree Laboratories, Inc. NDA Current 52268-302 NuLYTELY polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride Braintree Laboratories, Inc. NDA Current 52268-400 NuLYTELY With Flavor Packs Polyethylene Glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride Braintree Laboratories, Inc. NDA Current 52268-400 NuLYTELY With Flavor Packs Polyethylene Glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride Braintree Laboratories, Inc. NDA Current 52268-400 NuLYTELY With Flavor Packs Polyethylene Glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride Braintree Laboratories, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 67524 SUPPL 2021-05-18 67494 SUPPL 2021-05-17 43625 ORIG 2013-10-03 19227 SUPPL 2013-09-24 11724 SUPPL 2013-09-23 1627 SUPPL 2004-06-18