Application 020610

Type: NDA
Sponsor: VALEANT PHARMS INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COLAZAL	BALSALAZIDE DISODIUM	CAPSULE;ORAL	750MG	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
N020610-001	COLAZAL	BALSALAZIDE DISODIUM	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020610-001	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
N020610-001	7452872	2026-08-24	U-141
N020610-001	7625884	2026-08-24	U-141
N020610-001	7452872*PED	2027-02-24		Pediatric extension
N020610-001	7625884*PED	2027-02-24		Pediatric extension

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	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020610-001	COLAZAL	750MG	CAPSULE / ORAL	AB	RLD, RS	2000-07-18	`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	N020610-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020610-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020610-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020610-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020610-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020610-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020610-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020610-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020610-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020610-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020610-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020610-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020610-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020610-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020610-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020610-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020610-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020610-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020610-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020610-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020610-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020610-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020610-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020610-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020610-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020610-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020610-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020610-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020610-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020610-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020610-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020610-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020610-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020610-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020610-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020610-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020610-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020610-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020610-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020610-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020610-001	7452872	2026-08-24	U-141		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020610-001	7625884	2026-08-24	U-141		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020610-001	7452872*PED	2027-02-24		Pediatric extension	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020610-001	7625884*PED	2027-02-24		Pediatric extension	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020610-001	7452872	2026-08-24	U-141		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020610-001	7625884	2026-08-24	U-141		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020610-001	7452872*PED	2027-02-24		Pediatric extension	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020610-001	7625884*PED	2027-02-24		Pediatric extension	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020610-001	7452872	2026-08-24	U-141		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020610-001	7625884	2026-08-24	U-141		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020610-001	7452872*PED	2027-02-24		Pediatric extension	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020610-001	7625884*PED	2027-02-24		Pediatric extension	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020610-001	7452872	2026-08-24	U-141		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020610-001	7625884	2026-08-24	U-141		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020610-001	7452872*PED	2027-02-24		Pediatric extension	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020610-001	7625884*PED	2027-02-24		Pediatric extension	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020610-001	7452872	2026-08-24	U-141		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020610-001	7625884	2026-08-24	U-141		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020610-001	7452872*PED	2027-02-24		Pediatric extension	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020610-001	7625884*PED	2027-02-24		Pediatric extension	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020610-001	7452872	2026-08-24	U-141		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020610-001	7625884	2026-08-24	U-141		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020610-001	7452872*PED	2027-02-24		Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020610-001	7625884*PED	2027-02-24		Pediatric extension	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020610-001	7452872	2026-08-24	U-141		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020610-001	7625884	2026-08-24	U-141		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020610-001	7452872*PED	2027-02-24		Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020610-001	7625884*PED	2027-02-24		Pediatric extension	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020610-001	7452872	2026-08-24	U-141		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020610-001	7625884	2026-08-24	U-141		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020610-001	7452872*PED	2027-02-24		Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020610-001	7625884*PED	2027-02-24		Pediatric extension	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020610-001	7452872	2026-08-24	U-141		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020610-001	7625884	2026-08-24	U-141		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020610-001	7452872*PED	2027-02-24		Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020610-001	7625884*PED	2027-02-24		Pediatric extension	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020610-001	7452872	2026-08-24	U-141		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020610-001	7625884	2026-08-24	U-141		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020610-001	7452872*PED	2027-02-24		Pediatric extension	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020610-001	7625884*PED	2027-02-24		Pediatric extension	`d06236e962d9…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Balsalazide Disodium	BALSALAZIDE DISODIUM	AvPAK	509b83b6-cde6-393b-8560-557793b6a529	2025-12-30	Warnings, Adverse reactions	Name fallback generic name: BALSALAZIDE DISODIUM
Balsalazide Disodium	BALSALAZIDE DISODIUM	PD-Rx Pharmaceuticals, Inc.	b3ecc533-dd55-4a2f-84c4-ecd454aae766	2025-10-08	Warnings, Adverse reactions	Name fallback generic name: BALSALAZIDE DISODIUM
balsalazide disodium	BALSALAZIDE DISODIUM	Zydus Lifesciences Limited	c573888c-4aa3-4fdb-bf3f-1cf3d78d922b	2025-06-13	Warnings, Adverse reactions	Name fallback generic name: BALSALAZIDE DISODIUM
balsalazide disodium	BALSALAZIDE DISODIUM	Zydus Pharmaceuticals (USA) Inc.	0ed73067-e2ca-4184-a93a-5a2141bb4898	2025-06-13	Warnings, Adverse reactions	Name fallback generic name: BALSALAZIDE DISODIUM
balsalazide disodium	BALSALAZIDE DISODIUM	Carnegie Pharmaceuticals, LLC	620f86cb-b6a2-4af8-a642-925dd8a1c5fe	2025-04-15	Warnings, Adverse reactions	Name fallback generic name: BALSALAZIDE DISODIUM
Balsalazide Disodium	BALSALAZIDE DISODIUM	Bryant Ranch Prepack	cd73c9f1-d83b-4206-b2c6-1bd111e11263	2025-04-02	Warnings, Adverse reactions	Name fallback generic name: BALSALAZIDE DISODIUM
Balsalazide Disodium	BALSALAZIDE DISODIUM	Golden State Medical Supply, Inc.	029833fa-ec5c-6a39-e063-6294a90aa063	2025-02-18	Warnings, Adverse reactions	Name fallback generic name: BALSALAZIDE DISODIUM
Balsalazide Disodium	BALSALAZIDE DISODIUM	Apotex Corp.	f12ffa32-d14b-e9d9-e957-2ef08b64e8b4	2025-01-02	Warnings, Adverse reactions	Name fallback generic name: BALSALAZIDE DISODIUM
Balsalazide Disodium	BALSALAZIDE DISODIUM	Hikma Pharmaceuticals USA Inc.	a0498308-14b2-4456-8e13-795f6fc8ea30	2024-02-22	Warnings, Adverse reactions	Name fallback generic name: BALSALAZIDE DISODIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65649-101	Colazal	balsalazide disodium	Salix Pharmaceuticals, Inc	NDA AUTHORIZED GENERIC	Current
65649-101	Colazal	balsalazide disodium	Salix Pharmaceuticals, Inc	NDA AUTHORIZED GENERIC	Current
65649-101	Colazal	balsalazide disodium	Salix Pharmaceuticals, Inc	NDA AUTHORIZED GENERIC	Current
65649-101	Colazal	balsalazide disodium	Salix Pharmaceuticals, Inc	NDA AUTHORIZED GENERIC	Current
65649-101	Colazal	balsalazide disodium	Salix Pharmaceuticals, Inc	NDA AUTHORIZED GENERIC	Current
65649-101	Colazal	balsalazide disodium	Salix Pharmaceuticals, Inc	NDA AUTHORIZED GENERIC	Current
65649-101	Colazal	balsalazide disodium	Salix Pharmaceuticals, Inc	NDA AUTHORIZED GENERIC	Current
65649-101	Colazal	balsalazide disodium	Salix Pharmaceuticals, Inc	NDA AUTHORIZED GENERIC	Current
65649-101	Colazal	balsalazide disodium	Salix Pharmaceuticals, Inc	NDA AUTHORIZED GENERIC	Current
65649-101	Colazal	balsalazide disodium	Salix Pharmaceuticals, Inc	NDA AUTHORIZED GENERIC	Current
65649-101	Colazal	balsalazide disodium	Salix Pharmaceuticals, Inc	NDA	Current
65649-101	Colazal	balsalazide disodium	Salix Pharmaceuticals, Inc	NDA AUTHORIZED GENERIC	Current
68682-750	balsalazide disodium	balsalazide disodium	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-750	balsalazide disodium	balsalazide disodium	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-750	balsalazide disodium	balsalazide disodium	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75939	SUPPL	2023-10-25
75927	SUPPL	2023-10-25
72643	SUPPL	2022-11-17
72629	SUPPL	2022-11-17
69204	SUPPL	2021-11-02
69199	SUPPL	2021-11-02
64861	SUPPL	2020-10-07
64797	SUPPL	2020-10-02
59160	SUPPL	2019-07-31
59175	SUPPL	2019-06-27
2872	SUPPL	2008-07-14
2871	SUPPL	2007-11-08
12844	SUPPL	2007-11-07
34955	SUPPL	2006-12-28
25323	SUPPL	2006-12-28
25322	SUPPL	2006-09-25
12843	SUPPL	2006-09-25
25321	SUPPL	2006-03-23
2870	SUPPL	2002-06-18
34954	ORIG	2000-07-18
25320	ORIG	2000-07-18
20764	ORIG	2000-07-18
53530	SUPPL	1900-01-01
53529	SUPPL	1900-01-01
53079	ORIG	1900-01-01
51778	ORIG	1900-01-01
51777	ORIG	1900-01-01
51775	ORIG	1900-01-01