Home Applications 209589 Application 209589
Type NDA
Sponsor FERRING PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLENPIQ CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE SOLUTION;ORAL 12GM/BOT;3.5GM/BOT;10MG/BOT Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N209589-001 CLENPIQ CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209589-001 10624879 2034-06-23 Drug product 2020-05-04 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 N209589-001 12576072 2034-06-23 U-3261 Drug product 2026-04-14 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 N209589-001 12458634 2038-01-27 Drug product 2025-11-07
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 2 · 43 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 2026-09-14 22:38:34 2026-08 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 4 · 124 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209589-001 12576072 2034-06-23 U-3261 Drug product 2026-04-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209589-001 12458634 2038-01-27 Drug product 2025-11-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209589-001 12576072 2034-06-23 U-3261 Drug product 2026-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209589-001 12458634 2038-01-27 Drug product 2025-11-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209589-001 12458634 2038-01-27 Drug product 2025-11-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209589-001 12458634 2038-01-27 Drug product 2025-11-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 d06236e962d9…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2021-12-28 21:50 UTC 2021-12 N209589-001 NPP 2021-08-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209589-001 NPP 2021-08-15 87673890dc5c…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CLENPIQ SODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACID Ferring Pharmaceuticals Inc. e95fff66-4ec0-4001-a727-33e66a5ec7d5 2026-04-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 209589 application number: NDA209589 ndc (product): 55566-6800
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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55566-6700 CLENPIQ SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID Ferring Pharmaceuticals Inc. NDA Current 55566-6700 CLENPIQ SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID Ferring Pharmaceuticals Inc. NDA Current 55566-6700 CLENPIQ SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID Ferring Pharmaceuticals Inc. NDA Current 55566-6700 CLENPIQ SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID Ferring Pharmaceuticals Inc. NDA Current 55566-6700 CLENPIQ SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID Ferring Pharmaceuticals Inc. NDA Current 55566-6800 CLENPIQ SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID Ferring Pharmaceuticals Inc. NDA Current 72032-6700 CLENPIQ SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID ASM Aerosol-Service AG NDA Current