Application 213135

Type: NDA
Sponsor: BRAINTREE LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUTAB	SODIUM SULFATE;MAGNESIUM SULFATE;POTASSIUM	TABLET;ORAL	1.479G;0.225G;0.188G	Yes	No

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
N213135-001	SUTAB	MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE	0.225GM;0.188GM;1.479GM	TABLET / ORAL	AB	RLD, RS	2020-11-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N213135-001	AB

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
N213135-001	10143656	2037-08-04		Drug product	2020-11-13
N213135-001	11033498	2037-08-04	U-3164		2021-07-02
N213135-001	11382864	2037-08-04	U-3164		2022-08-04
N213135-001	11638697	2037-08-04		Drug product	2023-05-31

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	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213135-001	SUTAB (COPACKAGED)	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213135-001	SUTAB (COPACKAGED)	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213135-001	SUTAB (COPACKAGED)	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL		RLD, RS	2020-11-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213135-001	SUTAB	0.225GM;0.188GM;1.479GM	TABLET / ORAL	AB	RLD, RS	2020-11-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213135-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 118 observed states.

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	N213135-001	10143656	2037-08-04		Drug product	2020-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213135-001	11033498	2037-08-04	U-3164		2021-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213135-001	11382864	2037-08-04	U-3164		2022-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213135-001	11638697	2037-08-04		Drug product	2023-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213135-001	10143656	2037-08-04		Drug product	2020-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213135-001	11033498	2037-08-04	U-3164		2021-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213135-001	11382864	2037-08-04	U-3164		2022-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213135-001	11638697	2037-08-04		Drug product	2023-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213135-001	10143656	2037-08-04		Drug product	2020-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213135-001	11033498	2037-08-04	U-3164		2021-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213135-001	11382864	2037-08-04	U-3164		2022-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213135-001	11638697	2037-08-04		Drug product	2023-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213135-001	10143656	2037-08-04		Drug product	2020-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213135-001	11033498	2037-08-04	U-3164		2021-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213135-001	11382864	2037-08-04	U-3164		2022-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213135-001	11638697	2037-08-04		Drug product	2023-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213135-001	10143656	2037-08-04		Drug product	2020-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213135-001	11033498	2037-08-04	U-3164		2021-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213135-001	11382864	2037-08-04	U-3164		2022-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213135-001	11638697	2037-08-04		Drug product	2023-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213135-001	10143656	2037-08-04		Drug product	2020-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213135-001	11033498	2037-08-04	U-3164		2021-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213135-001	11382864	2037-08-04	U-3164		2022-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213135-001	11638697	2037-08-04		Drug product	2023-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213135-001	10143656	2037-08-04		Drug product	2020-11-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213135-001	11033498	2037-08-04	U-3164		2021-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213135-001	11382864	2037-08-04	U-3164		2022-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213135-001	11638697	2037-08-04		Drug product	2023-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213135-001	10143656	2037-08-04		Drug product	2020-11-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213135-001	11033498	2037-08-04	U-3164		2021-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213135-001	11382864	2037-08-04	U-3164		2022-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213135-001	11638697	2037-08-04		Drug product	2023-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213135-001	10143656	2037-08-04		Drug product	2020-11-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213135-001	11033498	2037-08-04	U-3164		2021-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213135-001	11382864	2037-08-04	U-3164		2022-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213135-001	11638697	2037-08-04		Drug product	2023-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213135-001	10143656	2037-08-04		Drug product	2020-11-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213135-001	11033498	2037-08-04	U-3164		2021-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213135-001	11382864	2037-08-04	U-3164		2022-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213135-001	11638697	2037-08-04		Drug product	2023-05-31	`d06236e962d9…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213135-001	NP	2023-11-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213135-001	NP	2023-11-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213135-001	NP	2023-11-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213135-001	NP	2023-11-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213135-001	NP	2023-11-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213135-001	NP	2023-11-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213135-001	NP	2023-11-10	`5aa47cf7b7d7…`
2023-12-20 04:57 UTC	2023-12	N213135-001	NP	2023-11-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213135-001	NP	2023-11-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213135-001	NP	2023-11-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213135-001	NP	2023-11-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213135-001	NP	2023-11-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213135-001	NP	2023-11-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213135-001	NP	2023-11-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213135-001	NP	2023-11-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213135-001	NP	2023-11-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213135-001	NP	2023-11-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213135-001	NP	2023-11-10	`cb3db0bc1861…`

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
SUTAB	SODIUM SULFATE, MAGNESIUM SULFATE, AND POTASSIUM CHLORIDE	Azurity Pharmaceuticals, Inc.	c020e973-dccf-4862-999e-17db6209a48a	2026-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213135 application number: NDA213135
SUTAB	SODIUM SULFATE, MAGNESIUM SULFATE, AND POTASSIUM CHLORIDE	Braintree Laboratories, Inc.	dddd2701-4d46-44de-a9f8-303d4dcceef7	2023-11-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213135 application number: NDA213135 ndc (product): 52268-201

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52268-201	SUTAB	sodium sulfate, magnesium sulfate, and potassium chloride	Braintree Laboratories, Inc.	NDA	Current
52268-201	SUTAB	sodium sulfate, magnesium sulfate, and potassium chloride	Braintree Laboratories, Inc.	NDA	Current
52268-201	SUTAB	sodium sulfate, magnesium sulfate, and potassium chloride	Braintree Laboratories, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75947	SUPPL	2023-10-25
75933	SUPPL	2023-10-25
75932	SUPPL	2023-10-25
70029	SUPPL	2022-02-01
70028	SUPPL	2022-02-01
70024	SUPPL	2022-02-01
66781	ORIG	2021-03-15
65201	ORIG	2020-11-12
65193	ORIG	2020-11-12
65182	ORIG	2020-11-10