Application 210742

Type: ANDA
Sponsor: ARISE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORTHALIDONE	CHLORTHALIDONE	TABLET;ORAL	25MG	No	No
002	CHLORTHALIDONE	CHLORTHALIDONE	TABLET;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210742-001	CHLORTHALIDONE	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2018-10-12
A210742-002	CHLORTHALIDONE	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2018-10-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210742-001	AB
A210742-002	AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210742-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210742-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210742-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210742-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210742-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210742-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210742-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210742-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210742-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210742-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210742-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210742-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210742-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210742-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210742-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210742-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210742-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210742-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210742-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210742-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210742-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-10-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210742-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210742-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-10-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210742-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210742-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-10-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210742-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210742-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-10-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210742-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210742-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-10-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210742-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210742-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-10-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210742-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210742-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-10-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210742-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-10-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210742-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-10-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210742-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-10-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210742-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-10-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210742-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-10-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210742-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-10-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210742-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-10-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A210742-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210742-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210742-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210742-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210742-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210742-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210742-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210742-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210742-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210742-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210742-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210742-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210742-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210742-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210742-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210742-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210742-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210742-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210742-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210742-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210742-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210742-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210742-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210742-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210742-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210742-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210742-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210742-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210742-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210742-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210742-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210742-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210742-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210742-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210742-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210742-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210742-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210742-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210742-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210742-002	AB	1	`782e0a99824c…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHLORTHALIDONE	CHLORTHALIDONE	AvPAK	972b801e-c4f2-4bd6-e053-2a95a90a53bb	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210742 application number: ANDA210742 ndc (product): 50268-167
CHLORTHALIDONE	CHLORTHALIDONE	Northwind Health Company, LLC	f319c0c7-182b-70ee-e053-2a95a90ac5ef	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210742 application number: ANDA210742
CHLORTHALIDONE	CHLORTHALIDONE	Northwind Health Company, LLC	f309b5df-ce39-0d55-e053-2995a90a7878	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210742 application number: ANDA210742
CHLORTHALIDONE	CHLORTHALIDONE	Aphena Pharma Solutions - Tennessee, LLC	e3ff03fd-bbab-4c8d-b24d-40c611db3bb3	2023-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210742 application number: ANDA210742 ndc (product): 71610-682
CHLORTHALIDONE	CHLORTHALIDONE	Dr. Reddy's Laboratories Inc.	bd2e4486-0720-4d09-b4f5-472c4478af0e	2022-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210742 application number: ANDA210742 ndc (product): 43598-167 ndc (product): 43598-170
CHLORTHALIDONE	CHLORTHALIDONE	Dr. Reddy's Laboratories Inc.	9e9e9ced-6960-4d2f-bb23-ef8b2435da75	2022-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210742 application number: ANDA210742 ndc (product): 43598-719 ndc (product): 43598-720

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43598-167	CHLORTHALIDONE	CHLORTHALIDONE	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-170	CHLORTHALIDONE	CHLORTHALIDONE	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-719	CHLORTHALIDONE	CHLORTHALIDONE	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-719	CHLORTHALIDONE	CHLORTHALIDONE	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-719	CHLORTHALIDONE	CHLORTHALIDONE	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-719	CHLORTHALIDONE	CHLORTHALIDONE	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-719	CHLORTHALIDONE	CHLORTHALIDONE	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-720	CHLORTHALIDONE	CHLORTHALIDONE	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-720	CHLORTHALIDONE	CHLORTHALIDONE	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-720	CHLORTHALIDONE	CHLORTHALIDONE	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-720	CHLORTHALIDONE	CHLORTHALIDONE	Dr. Reddy's Laboratories Inc.	ANDA	Current
43598-720	CHLORTHALIDONE	CHLORTHALIDONE	Dr. Reddy's Laboratories Inc.	ANDA	Current
50268-167	CHLORTHALIDONE	CHLORTHALIDONE	AvPAK	ANDA	Current
50268-167	CHLORTHALIDONE	CHLORTHALIDONE	AvPAK	ANDA	Current
50268-167	CHLORTHALIDONE	CHLORTHALIDONE	AvPAK	ANDA	Current
55801-145	CHLORTHALIDONE	CHLORTHALIDONE	Appco Pharma LLC	ANDA	Current
55801-146	CHLORTHALIDONE	CHLORTHALIDONE	Appco Pharma LLC	ANDA	Current
55801-146	CHLORTHALIDONE	CHLORTHALIDONE	Appco Pharma LLC	ANDA	Current
70518-2690	CHLORTHALIDONE	CHLORTHALIDONE	REMEDYREPACK INC.	ANDA	Current
70518-2690	CHLORTHALIDONE	CHLORTHALIDONE	REMEDYREPACK INC.	ANDA	Current
70518-2690	CHLORTHALIDONE	CHLORTHALIDONE	REMEDYREPACK INC.	ANDA	Current
70518-2690	CHLORTHALIDONE	CHLORTHALIDONE	REMEDYREPACK INC.	ANDA	Current
71610-682	CHLORTHALIDONE	CHLORTHALIDONE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current