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 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
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 1 of 2 · 41 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
2026-02-19 14:30 UTC	2026-02	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`3a93d1ddd44b…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022372-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022372-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022372-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022372-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022372-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022372-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022372-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022372-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022372-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022372-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022372-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022372-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022372-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022372-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022372-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022372-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022372-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022372-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022372-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022372-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022372-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022372-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022372-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022372-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022372-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022372-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022372-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022372-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022372-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022372-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022372-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022372-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022372-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022372-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022372-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022372-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022372-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022372-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022372-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022372-001	AA	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022372-001	ODE-315	2027-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022372-001	ODE-315	2027-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022372-001	ODE-315	2027-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022372-001	ODE-315	2027-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022372-001	ODE-315	2027-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022372-001	ODE-315	2027-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022372-001	ODE-315	2027-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022372-001	ODE-315	2027-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022372-001	ODE-315	2027-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022372-001	ODE-315	2027-08-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022372-001	ODE-315	2027-08-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022372-001	ODE-315	2027-08-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022372-001	ODE-315	2027-08-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022372-001	ODE-315	2027-08-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022372-001	ODE-315	2027-08-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022372-001	ODE-315	2027-08-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022372-001	ODE-315	2027-08-05	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022372-001	ODE-315	2027-08-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022372-001	ODE-315	2027-08-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022372-001	ODE-315	2027-08-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022372-001	ODE-315	2027-08-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022372-001	ODE-315	2027-08-05	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022372-001	ODE-315	2027-08-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022372-001	ODE-315	2027-08-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022372-001	ODE-315	2027-08-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022372-001	ODE-315	2027-08-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022372-001	ODE-315	2027-08-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022372-001	ODE-315	2027-08-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022372-001	ODE-315	2027-08-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022372-001	ODE-315	2027-08-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022372-001	ODE-315	2027-08-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022372-001	ODE-315	2027-08-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022372-001	ODE-315	2027-08-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022372-001	ODE-315	2027-08-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022372-001	ODE-315	2027-08-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022372-001	ODE-315	2027-08-05	`a50c72e98297…`

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 · 4 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
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE	Affordable Pharmaceuticals, LLC	f86bdcc8-e643-4160-89ae-01c89bee842d	2025-11-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022372 application number: NDA022372 ndc (product): 10572-112 ndc (product): 10572-012
SUPREP Bowel Prep	SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE	Braintree Laboratories, Inc.	2f5f06de-ee98-44c0-be7e-9a998d1e5c16	2025-11-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022372 application number: NDA022372 ndc (product): 52268-112 ndc (product): 52268-012

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84228	SUPPL	2025-11-19
84227	SUPPL	2025-11-19
84220	SUPPL	2025-11-19
64219	SUPPL	2020-08-06
64210	SUPPL	2020-08-06
64209	SUPPL	2020-08-06
29660	SUPPL	2012-11-06
17302	SUPPL	2012-11-02
42501	ORIG	2011-09-16
24291	ORIG	2011-09-16
7304	SUPPL	2011-07-12
43856	ORIG	2010-08-10
38632	ORIG	2010-08-10
29659	ORIG	2010-08-10