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 3 of 4 · 79 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorthalidone	CHLORTHALIDONE	Ascend Laboratories, LLC	d104583e-e983-4230-b6d1-4455ee1060a5	2025-04-23	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
HEMICLOR	CHLORTHALIDONE	Ingenus Pharmaceuticals, LLC	3f0f3ee0-f5a6-4bda-8160-a77744e9fa46	2025-03-27	Warnings, Adverse reactions	Name fallback generic name: CHLORTHALIDONE
CHLORTHALIDONE	CHLORTHALIDONE	Lifestar Pharma LLC	c8e2b475-a8e9-4aa9-b4e9-66d746bbdc70	2025-03-07	Warnings, Adverse reactions	Name fallback brand name: CHLORTHALIDONE generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	bcd2b6f8-533a-4f50-b3e6-80427e6c19ac	2025-01-29	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Coupler LLC	2ccba8ab-4c34-af52-e063-6394a90a78d3	2025-01-28	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Coupler LLC	2ccc5376-5fb0-dd09-e063-6294a90af563	2025-01-28	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	5441e163-459a-46b0-87a9-e9879091bf3c	2025-01-28	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	ac431d1b-b307-46fe-a3a9-29f40fe6742b	2025-01-24	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Direct_Rx	deab1d3e-759f-480e-e053-2995a90a0a75	2025-01-22	Warnings	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Direct_Rx	03204a70-d53b-0e44-e063-6394a90a2aab	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	PD-Rx Pharmaceuticals, Inc.	08b7ee65-53a5-ffbb-e063-6294a90ad4ee	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Zydus Lifesciences Limited	6b432c76-b171-4c29-abf4-6d357976e6ef	2024-11-26		Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
CHLORTHALIDONE	CHLORTHALIDONE	Rising Pharma Holdings, Inc.	71b1d074-0521-4cd1-beb5-fedd61f52eca	2024-11-05	Warnings, Adverse reactions	Name fallback brand name: CHLORTHALIDONE generic name: CHLORTHALIDONE
CHLORTHALIDONE	CHLORTHALIDONE	Bryant Ranch Prepack	3c76c7a6-abfb-4dc1-ad5a-d7d00cb832cb	2024-08-22	Warnings, Adverse reactions	Name fallback brand name: CHLORTHALIDONE generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	e727d42f-e4e1-4cf6-9d7a-6ec2333bc6d1	2024-01-11	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	a1ab541b-7515-4888-b3e0-aca52875562d	2024-01-11	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	A-S Medication Solutions	1b1ff6c9-2367-4446-87a6-be86c0efd8e1	2023-12-26	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	A-S Medication Solutions	14f9e2c6-ceb0-4306-9936-ca109912de12	2023-12-26	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
CHLORTHALIDONE	CHLORTHALIDONE	Bryant Ranch Prepack	1ba595d4-b105-4d52-90dd-0fb8bda1fe1b	2023-11-30	Warnings, Adverse reactions	Name fallback brand name: CHLORTHALIDONE generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	98f4a14c-2863-4068-bd35-aaedcc872680	2023-11-27	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.