Application 089286

Type: ANDA
Sponsor: SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORTHALIDONE	CHLORTHALIDONE	TABLET;ORAL	50MG	No	No
002	CHLORTHALIDONE	CHLORTHALIDONE	TABLET;ORAL	25MG	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
A089286-001	CHLORTHALIDONE	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		1986-07-21
A089286-002	CHLORTHALIDONE	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		1986-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089286-001	AB
A089286-002	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	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089286-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	1986-07-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A089286-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	1986-07-21	`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	A089286-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089286-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089286-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089286-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089286-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089286-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089286-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089286-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089286-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089286-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089286-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089286-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089286-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089286-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089286-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089286-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089286-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089286-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089286-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089286-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089286-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089286-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089286-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089286-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089286-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089286-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089286-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A089286-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089286-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089286-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089286-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A089286-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089286-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A089286-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089286-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A089286-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089286-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A089286-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089286-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A089286-002	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorthalidone	CHLORTHALIDONE	Major Pharmaceuticals	2de92cea-8f03-4af0-9d91-d4578510cc53	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089286 application number: ANDA089286 ndc (product): 0904-6900
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	6e5cc0d8-6575-4675-bd8b-9a21b206aae1	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089286 application number: ANDA089286
Chlorthalidone	CHLORTHALIDONE	American Health Packaging	b1ff748d-36e9-4327-aa8a-e8fb22a9d637	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089286 application number: ANDA089286 ndc (product): 60687-317
Chlorthalidone	CHLORTHALIDONE	PD-Rx Pharmaceuticals, Inc.	08b7ee65-53a5-ffbb-e063-6294a90ad4ee	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089286 application number: ANDA089286
Chlorthalidone	CHLORTHALIDONE	Sun Pharmaceutical Industries, Inc.	a304de67-cd2b-4933-937e-4eeecf6cda40	2022-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089286 application number: ANDA089286 ndc (product): 57664-649 ndc (product): 57664-648
Chlorthalidone	CHLORTHALIDONE	Aphena Pharma Solutions - Tennessee, LLC	dea660bd-d4cc-4c5b-9c6d-674a6dc1c9c2	2021-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089286 application number: ANDA089286 ndc (product): 71610-029
Chlorthalidone	CHLORTHALIDONE	Aphena Pharma Solutions - Tennessee, LLC	5ea42479-84f4-434d-b65b-de34a7a57926	2017-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089286 application number: ANDA089286 ndc (product): 71610-021

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6900	Chlorthalidone	Chlorthalidone	Major Pharmaceuticals	ANDA	Current
0904-6900	Chlorthalidone	Chlorthalidone	Major Pharmaceuticals	ANDA	Current
16714-800	Chlorthalidone	Chlorthalidone	Northstar Rx LLC	ANDA	Current
16714-800	Chlorthalidone	Chlorthalidone	Northstar Rx LLC	ANDA	Current
16714-800	Chlorthalidone	Chlorthalidone	Northstar Rx LLC	ANDA	Current
16714-801	Chlorthalidone	Chlorthalidone	Northstar Rx LLC	ANDA	Current
50090-3161	Chlorthalidone	Chlorthalidone	A-S Medication Solutions	ANDA	Current
50090-3161	Chlorthalidone	Chlorthalidone	A-S Medication Solutions	ANDA	Current
50090-3910	Chlorthalidone	Chlorthalidone	A-S Medication Solutions	ANDA	Current
50090-3910	Chlorthalidone	Chlorthalidone	A-S Medication Solutions	ANDA	Current
50090-4223	Chlorthalidone	Chlorthalidone	A-S Medication Solutions	ANDA	Current
57664-648	Chlorthalidone	Chlorthalidone	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-648	Chlorthalidone	Chlorthalidone	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-648	Chlorthalidone	Chlorthalidone	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-649	Chlorthalidone	Chlorthalidone	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-649	Chlorthalidone	Chlorthalidone	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-649	Chlorthalidone	Chlorthalidone	Sun Pharmaceutical Industries, Inc.	ANDA	Current
60687-317	Chlorthalidone	Chlorthalidone	American Health Packaging	ANDA	Current
60687-317	Chlorthalidone	Chlorthalidone	American Health Packaging	ANDA	Current
60687-317	Chlorthalidone	Chlorthalidone	American Health Packaging	ANDA	Current
60687-317	Chlorthalidone	Chlorthalidone	American Health Packaging	ANDA	Current
68071-2037	Chlorthalidone	Chlorthalidone	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4018	Chlorthalidone	Chlorthalidone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4018	Chlorthalidone	Chlorthalidone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68151-2760	Chlorthalidone	Chlorthalidone	Carilion Materials Management	ANDA	Current
68788-6852	Chlorthalidone	Chlorthalidone	Preferred Pharmaceuticals Inc.	ANDA	Current
71610-021	Chlorthalidone	Chlorthalidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-029	Chlorthalidone	Chlorthalidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-029	Chlorthalidone	Chlorthalidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current