Application 214129

Type: ANDA
Sponsor: AJANTA PHARMA LTD

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
A214129-001	CHLORTHALIDONE	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-11-27
A214129-002	CHLORTHALIDONE	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214129-001	AB
A214129-002	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 2 · 72 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	A214129-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2020-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214129-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2020-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214129-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2020-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214129-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2020-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214129-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2020-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214129-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2020-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214129-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2020-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214129-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2020-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214129-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2020-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214129-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2020-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214129-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2020-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214129-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2020-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214129-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2020-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214129-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2020-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214129-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2020-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214129-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2020-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214129-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2020-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214129-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2020-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214129-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2020-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214129-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2020-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214129-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2020-11-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214129-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2020-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214129-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2020-11-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214129-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2020-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214129-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2020-11-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214129-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2020-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214129-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2020-11-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214129-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2020-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214129-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2020-11-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214129-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2020-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214129-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2020-11-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214129-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2020-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214129-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2020-11-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214129-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2020-11-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214129-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2020-11-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214129-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2020-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214129-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2020-11-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214129-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2020-11-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214129-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2020-11-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214129-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2020-11-27	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 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	A214129-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214129-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214129-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214129-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214129-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214129-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214129-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214129-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214129-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214129-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214129-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214129-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214129-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214129-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214129-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214129-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214129-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214129-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214129-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214129-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214129-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214129-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214129-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214129-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214129-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214129-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214129-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214129-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214129-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214129-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214129-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214129-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214129-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214129-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214129-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214129-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214129-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214129-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214129-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214129-002	AB	1	`87673890dc5c…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorthalidone	CHLORTHALIDONE	Preferred Pharmaceuticals Inc.	180cc3c7-6ab7-481b-b860-b20d3599e53f	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214129 application number: ANDA214129 ndc (product): 68788-8294
Chlorthalidone	CHLORTHALIDONE	Northwind Health Company, LLC	e3b09f77-8ad2-233d-e053-2995a90a60c8	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214129 application number: ANDA214129
Chlorthalidone	CHLORTHALIDONE	Ajanta Pharma USA Inc.	284f4707-14ab-426f-80d6-79f1186419f9	2025-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214129 application number: ANDA214129 ndc (product): 27241-217 ndc (product): 27241-216
Chlorthalidone	CHLORTHALIDONE	Direct_Rx	03204a70-d53b-0e44-e063-6394a90a2aab	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214129 application number: ANDA214129
Chlorthalidone	CHLORTHALIDONE	A-S Medication Solutions	b3f053cd-7118-4602-9b15-7f7fd143b8c2	2023-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214129 application number: ANDA214129 ndc (product): 50090-5643

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27241-216	Chlorthalidone	Chlorthalidone	Ajanta Pharma USA Inc.	ANDA	Current
27241-216	Chlorthalidone	Chlorthalidone	Ajanta Pharma Limited	ANDA	Current
27241-217	Chlorthalidone	Chlorthalidone	Ajanta Pharma USA Inc.	ANDA	Current
27241-217	Chlorthalidone	Chlorthalidone	Ajanta Pharma Limited	ANDA	Current
50090-5643	Chlorthalidone	Chlorthalidone	A-S Medication Solutions	ANDA	Current
50090-5643	Chlorthalidone	Chlorthalidone	A-S Medication Solutions	ANDA	Current
50090-5860	Chlorthalidone	Chlorthalidone	A-S Medication Solutions	ANDA	Current
68788-8294	Chlorthalidone	Chlorthalidone	Preferred Pharmaceuticals Inc.	ANDA	Current
70934-938	Chlorthalidone	Chlorthalidone	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-938	Chlorthalidone	Chlorthalidone	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current