Home Applications 215344 Application 215344
Type NDA
Sponsor AZURITY Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SUFLAVE MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE FOR SOLUTION;ORAL 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N215344-001 SUFLAVE MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215344-001 12239659 2044-06-14 U-4143 2025-03-04 N215344-001 12433914 2044-06-14 U-4143 2025-11-06 N215344-001 12594298 2044-06-14 Drug product 2026-04-24 N215344-001 12290529 2044-08-02 Drug product 2025-05-09
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215344-001 NP 2026-06-15
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 table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 a67488948f0b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 a50c72e98297…
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 2026-02-19 14:30 UTC 2026-02 N215344-001 12239659 2044-06-14 U-4143 2025-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215344-001 12433914 2044-06-14 U-4143 2025-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215344-001 12290529 2044-08-02 Drug product 2025-05-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215344-001 12239659 2044-06-14 U-4143 2025-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215344-001 12433914 2044-06-14 U-4143 2025-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215344-001 12290529 2044-08-02 Drug product 2025-05-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215344-001 12239659 2044-06-14 U-4143 2025-03-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215344-001 12290529 2044-08-02 Drug product 2025-05-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215344-001 12239659 2044-06-14 U-4143 2025-03-04 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215344-001 12239659 2044-06-14 U-4143 2025-03-04 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215344-001 12433914 2044-06-14 U-4143 2025-11-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215344-001 12594298 2044-06-14 Drug product 2026-04-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215344-001 12290529 2044-08-02 Drug product 2025-05-09 a50c72e98297…
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 SUFLAVE POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, AND SODIUM CHLORIDE FOR ORAL SOLUTION Azurity Pharmaceuticals, Inc. d5710a04-2b0a-402c-a8b0-025766f1a437 2026-01-31 Warnings, Adverse reactions Exact identifier application applno (NDA): 215344 application number: NDA215344 SUFLAVE POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, AND SODIUM CHLORIDE FOR ORAL SOLUTION Braintree Laboratories, Inc. 546cfc44-791c-4524-99a9-6a0af96c4ec8 2023-06-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 215344 application number: NDA215344
Documents# Document, Submission type, Date table Document Submission type Date 77406 ORIG 2024-01-26 74523 ORIG 2023-06-16 74504 ORIG 2023-06-16 74503 ORIG 2023-06-16