Application 202535

Type
NDA
Sponsor
FERRING PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREPOPIKCITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATEFOR SOLUTION;ORAL12GM/PACKET;3.5GM/PACKET;10MG/PACKETYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N202535-001PREPOPIKCITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-16

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N202535-00184503382028-10-10Drug product2013-05-28
N202535-00184810832028-10-10Drug product2013-07-09

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKETFOR SOLUTION / ORALRLD2012-07-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKETFOR SOLUTION / ORALRLD2012-07-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKETFOR SOLUTION / ORALRLD2012-07-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**FOR SOLUTION / ORALRLD2012-07-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**FOR SOLUTION / ORALRLD2012-07-1687673890dc5c…
2021-03-12 10:30 UTC2021-03N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**FOR SOLUTION / ORALRLD2012-07-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKETFOR SOLUTION / ORALRLD2012-07-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKETFOR SOLUTION / ORALRLD2012-07-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKETFOR SOLUTION / ORALRLD2012-07-163f01610625f2…
2019-09-15 20:21 UTC2019-09N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKETFOR SOLUTION / ORALRLD, RS2012-07-16b00525d2431f…
2019-07-19 19:46 UTC2019-07N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKETFOR SOLUTION / ORALRLD, RS2012-07-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-163f0d92c62455…
2023-05-13 08:27 UTC2023-05N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-16053a50430f4f…
2023-01-26 05:58 UTC2023-01N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N202535-001PREPOPIK12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD2012-07-16e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N202535-00184503382028-10-10Drug product2013-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07N202535-00184810832028-10-10Drug product2013-07-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N202535-00184503382028-10-10Drug product2013-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202535-00184810832028-10-10Drug product2013-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202535-00184503382028-10-10Drug product2013-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202535-00184810832028-10-10Drug product2013-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N202535-00184503382028-10-10Drug product2013-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202535-00184810832028-10-10Drug product2013-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202535-00184503382028-10-10Drug product2013-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202535-00184810832028-10-10Drug product2013-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202535-00184503382028-10-10Drug product2013-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202535-00184810832028-10-10Drug product2013-07-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202535-00184503382028-10-10Drug product2013-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202535-00184810832028-10-10Drug product2013-07-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202535-00184503382028-10-10Drug product2013-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202535-00184810832028-10-10Drug product2013-07-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202535-00184503382028-10-10Drug product2013-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202535-00184810832028-10-10Drug product2013-07-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202535-00184503382028-10-10Drug product2013-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202535-00184810832028-10-10Drug product2013-07-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202535-00184503382028-10-10Drug product2013-05-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N202535-00184810832028-10-10Drug product2013-07-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202535-00184503382028-10-10Drug product2013-05-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202535-00184810832028-10-10Drug product2013-07-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202535-00184503382028-10-10Drug product2013-05-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202535-00184810832028-10-10Drug product2013-07-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202535-00184503382028-10-10Drug product2013-05-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202535-00184810832028-10-10Drug product2013-07-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202535-00184503382028-10-10Drug product2013-05-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05N202535-00184810832028-10-10Drug product2013-07-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202535-00184503382028-10-10Drug product2013-05-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202535-00184810832028-10-10Drug product2013-07-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N202535-00184503382028-10-10Drug product2013-05-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N202535-00184810832028-10-10Drug product2013-07-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N202535-00184503382028-10-10Drug product2013-05-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N202535-00184810832028-10-10Drug product2013-07-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N202535-00184503382028-10-10Drug product2013-05-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202535-00184810832028-10-10Drug product2013-07-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N202535-00184503382028-10-10Drug product2013-05-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N202535-00184810832028-10-10Drug product2013-07-09bb7c543d1eb4…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N202535-001NPP2021-08-1574a2ff9319b5…
2021-12-28 21:50 UTC2021-12N202535-001NPP2021-08-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N202535-001NPP2021-08-1587673890dc5c…
2021-03-12 10:30 UTC2021-03N202535-001NPP2021-08-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N202535-001NPP2021-08-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11N202535-001NPP2021-08-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12N202535-001NPP2021-08-153f01610625f2…
2019-09-15 20:21 UTC2019-09N202535-001NPP2021-08-15b00525d2431f…
2019-07-19 19:46 UTC2019-07N202535-001NPP2021-08-15ea99ee380514…

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55566-9300PREPOPIKSODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.NDACurrent
55566-9300PREPOPIKSODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.NDACurrent
55566-9300PREPOPIKSODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.NDACurrent
55566-9300PREPOPIKSODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.NDACurrent
55566-9700PREPOPIKSODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.NDACurrent
55566-9700PREPOPIKSODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.NDACurrent
55566-9700PREPOPIKSODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.NDACurrent
55566-9700PREPOPIKSODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75325SUPPL 2023-08-31
75324SUPPL 2023-08-31
75321SUPPL 2023-08-30
55208SUPPL2018-08-20
55189SUPPL2018-08-16
55188SUPPL2018-08-16
24419ORIG2012-08-03
22891ORIG2012-08-03
19358ORIG2012-07-18
10068ORIG2012-07-17
63266SUPPL1900-01-01