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 4 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	f19b9a1c-1a43-4317-a016-6104391730dc	2023-11-27	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	A-S Medication Solutions	c5796482-ad1f-437a-ae80-c288880f4100	2023-10-16	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	68244f44-42e9-46b6-86f8-85ab0c4b2b26	2023-09-20	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	A-S Medication Solutions	b3f053cd-7118-4602-9b15-7f7fd143b8c2	2023-09-17	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
CHLORTHALIDONE	CHLORTHALIDONE	Aphena Pharma Solutions - Tennessee, LLC	e3ff03fd-bbab-4c8d-b24d-40c611db3bb3	2023-01-04	Warnings, Adverse reactions	Name fallback brand name: CHLORTHALIDONE generic name: CHLORTHALIDONE
CHLORTHALIDONE	CHLORTHALIDONE	Dr. Reddy's Laboratories Inc.	bd2e4486-0720-4d09-b4f5-472c4478af0e	2022-12-06	Warnings, Adverse reactions	Name fallback brand name: CHLORTHALIDONE generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Northstar Rx LLC.	56635d7a-1fff-4d1f-bf2c-def4b1ad8208	2022-11-24	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Unichem Pharmaceuticals (USA), Inc.	01065eda-7515-46bc-b858-a062c3aa35bd	2022-11-24	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Sun Pharmaceutical Industries, Inc.	a304de67-cd2b-4933-937e-4eeecf6cda40	2022-11-04	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
CHLORTHALIDONE	CHLORTHALIDONE	JUBILANT CADISTA PHARMACEUTICALS,INC.	ca0df4ae-c424-44d2-8611-1637f1a101a8	2022-11-03	Warnings, Adverse reactions	Name fallback brand name: CHLORTHALIDONE generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Zydus Pharmaceuticals USA Inc.	ef8023a3-b2be-436e-9085-576781950665	2022-10-05	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
CHLORTHALIDONE CHLORTHALIDONE	CHLORTHALIDONE	Alembic Pharmaceuticals Limited	1b98d1a1-9d3d-41d2-a5e9-744b851d30d4	2022-09-06	Warnings, Adverse reactions	Name fallback generic name: CHLORTHALIDONE
CHLORTHALIDONE CHLORTHALIDONE	CHLORTHALIDONE	Alembic Pharmaceuticals Inc.	a1043a72-8e64-49da-a7e4-eadee083022e	2022-08-29	Warnings, Adverse reactions	Name fallback generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	TAGI Pharma, Inc.	bd92c59b-3a65-47c3-b3c8-37090b4ae464	2022-06-22	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Proficient Rx LP	01337f79-4b3d-4749-a82b-8d56c1aec179	2022-05-01	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
CHLORTHALIDONE	CHLORTHALIDONE	Dr. Reddy's Laboratories Inc.	9e9e9ced-6960-4d2f-bb23-ef8b2435da75	2022-01-12	Warnings, Adverse reactions	Name fallback brand name: CHLORTHALIDONE generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Aphena Pharma Solutions - Tennessee, LLC	dea660bd-d4cc-4c5b-9c6d-674a6dc1c9c2	2021-08-03	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
CHLORTHALIDONE	CHLORTHALIDONE	Aphena Pharma Solutions - Tennessee, LLC	aa16c3fe-c00b-4b49-bfe3-3b3f93bd647a	2020-10-28	Warnings, Adverse reactions	Name fallback brand name: CHLORTHALIDONE generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Aphena Pharma Solutions - Tennessee, LLC	5ea42479-84f4-434d-b65b-de34a7a57926	2017-12-20	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.