Application 209162

Type: ANDA
Sponsor: IPCA LABS 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 43.

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
A209162-001	CHLORTHALIDONE	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2024-11-12
A209162-002	CHLORTHALIDONE	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2024-11-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209162-001	AB
A209162-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209162-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2024-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209162-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2024-11-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209162-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2024-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209162-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2024-11-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209162-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2024-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209162-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2024-11-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209162-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2024-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209162-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2024-11-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209162-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2024-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209162-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2024-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209162-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2024-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209162-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2024-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209162-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2024-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209162-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2024-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209162-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2024-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209162-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2024-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209162-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2024-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209162-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2024-11-12	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209162-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2024-11-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209162-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2024-11-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209162-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209162-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209162-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209162-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209162-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209162-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209162-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209162-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209162-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209162-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209162-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209162-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209162-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209162-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209162-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209162-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209162-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209162-002	AB	1	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209162-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209162-002	AB	1	`a50c72e98297…`

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 2 of 4 · 79 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	6e5cc0d8-6575-4675-bd8b-9a21b206aae1	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Mylan Institutional Inc.	193c85ba-43c2-4be2-82cf-7b394a83390e	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
CHLORTHALIDONE	CHLORTHALIDONE	Major Pharmaceuticals	d07eea8b-361b-486a-a572-3bf4a257f431	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: CHLORTHALIDONE generic name: CHLORTHALIDONE
CHLORTHALIDONE	CHLORTHALIDONE	Northwind Health Company, LLC	f319c0c7-182b-70ee-e053-2a95a90ac5ef	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: CHLORTHALIDONE generic name: CHLORTHALIDONE
CHLORTHALIDONE	CHLORTHALIDONE	Northwind Health Company, LLC	f309b5df-ce39-0d55-e053-2995a90a7878	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: CHLORTHALIDONE generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Northwind Health Company, LLC	da829c8c-ae13-510b-e053-2995a90a70b8	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Northwind Health Company, LLC	df6271ff-f111-fd4a-e053-2a95a90a4b51	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Northwind Health Company, LLC	e3b09f77-8ad2-233d-e053-2995a90a60c8	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	A-S Medication Solutions	7d09c992-22f7-41e1-a836-380712f242c0	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Chartwell RX, LLC	648f005f-1eae-4718-bc3a-2587d706fae2	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Nivagen Pharmaceuticals, INC.	36ef8d83-45f2-4873-b7cb-1be096d14d18	2025-12-09	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Ajanta Pharma USA Inc.	284f4707-14ab-426f-80d6-79f1186419f9	2025-11-30	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Preferred Pharmaceuticals Inc.	d61367af-530b-4e5e-8e71-11c93f75ecf1	2025-11-17	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	American Health Packaging	b1ff748d-36e9-4327-aa8a-e8fb22a9d637	2025-11-13	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	5979af5a-0c5b-40f9-bb67-2d462e1cefb7	2025-11-11	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	d8373bde-c8c9-445a-8933-49394023414a	2025-10-28	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Direct_Rx	401ae38b-2eb8-c9fc-e063-6294a90af220	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	165e5993-eb9d-4664-97dc-574ae5e0e946	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
CHLORTHALIDONE	CHLORTHALIDONE	Bryant Ranch Prepack	d867a784-54f0-4cce-9306-f92de095e855	2025-05-13	Warnings, Adverse reactions	Name fallback brand name: CHLORTHALIDONE generic name: CHLORTHALIDONE
CHLORTHALIDONE	CHLORTHALIDONE	Rising Pharma Holdings, Inc.	f96b2d0b-a141-4efb-8ccc-c447dfc6024a	2025-04-29	Warnings, Adverse reactions	Name fallback brand name: CHLORTHALIDONE generic name: CHLORTHALIDONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.