Home Applications 022372 Application 022372
Type NDA
Sponsor BRAINTREE LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SUPREP BOWEL PREP KIT MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE SOLUTION;ORAL 1.6GM/BOT;3.13GM/BOT;17.5GM/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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022372-001 SUPREP BOWEL PREP KIT MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA RLD, RS 2010-08-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022372-001 AA
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N022372-001 ODE-315 2027-08-05
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 2 · 44 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 2022-10-28 04:53 UTC 2022-10 N022372-001 SUPREP BOWEL PREP KIT 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA RLD, RS 2010-08-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022372-001 SUPREP BOWEL PREP KIT 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA RLD, RS 2010-08-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022372-001 SUPREP BOWEL PREP KIT 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA RLD, RS 2010-08-05 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022372-001 SUPREP BOWEL PREP KIT 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA RLD, RS 2010-08-05 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022372-001 6946149 2023-03-07 U-837 Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022372-001 6946149 2023-03-07 U-837 Drug product 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022372-001 6946149 2023-03-07 U-837 Drug product 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022372-001 6946149 2023-03-07 U-837 Drug product 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022372-001 6946149 2023-03-07 U-837 Drug product bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022372-001 6946149 2023-03-07 U-837 Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022372-001 6946149 2023-03-07 U-837 Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022372-001 6946149 2023-03-07 U-837 Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022372-001 6946149 2023-03-07 U-837 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022372-001 6946149 2023-03-07 U-837 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022372-001 6946149 2023-03-07 U-837 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022372-001 6946149 2023-03-07 U-837 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022372-001 6946149 2023-03-07 U-837 Drug product ea99ee380514…2023-12-20 04:57 UTC 2023-12 N022372-001 6946149 2023-03-07 U-837 Drug product ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022372-001 6946149 2023-03-07 U-837 Drug product a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022372-001 6946149 2023-03-07 U-837 Drug product 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022372-001 6946149 2023-03-07 U-837 Drug product a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022372-001 6946149 2023-03-07 U-837 Drug product 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022372-001 6946149 2023-03-07 U-837 Drug product 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022372-001 6946149 2023-03-07 U-837 Drug product 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022372-001 6946149 2023-03-07 U-837 Drug product 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022372-001 6946149 2023-03-07 U-837 Drug product f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022372-001 6946149 2023-03-07 U-837 Drug product e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022372-001 6946149 2023-03-07 U-837 Drug product cb3db0bc1861…
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 · 2 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE Wilshire Pharmaceuticals, Inc. f269929e-c2ff-4288-9d3b-7770bcb5a498 2026-04-13 Warnings, Adverse reactions Exact identifier application applno (NDA): 022372 application number: NDA022372 SUPREP Bowel Prep SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE Azurity Pharmaceuticals, Inc. 50f23abd-6a66-44cb-960e-d43c16a5ae5f 2026-01-31 Warnings, Adverse reactions Exact identifier application applno (NDA): 022372 application number: NDA022372
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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10572-012 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE sodium sulfate, potassium sulfate, magnesium sulfate Affordable Pharmaceuticals, LLC NDA Current 10572-112 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE sodium sulfate, potassium sulfate, magnesium sulfate Affordable Pharmaceuticals, LLC NDA Current 52268-012 SUPREP Bowel Prep sodium sulfate, potassium sulfate, magnesium sulfate Braintree Laboratories, Inc. NDA Current 52268-012 SUPREP Bowel Prep sodium sulfate, potassium sulfate, magnesium sulfate Braintree Laboratories, Inc. NDA Current 52268-112 SUPREP Bowel Prep sodium sulfate, potassium sulfate, magnesium sulfate Braintree Laboratories, Inc. NDA Current