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 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
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
2026-02-19 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
2026-02-19 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 1 of 4 · 79 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorthalidone	CHLORTHALIDONE	Macleods Pharmaceuticals Limited	5de362df-8fb9-4421-864c-7ea06339d6e7	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Major Pharmaceuticals	2de92cea-8f03-4af0-9d91-d4578510cc53	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
CHLORTHALIDONE	CHLORTHALIDONE	Preferred Pharmaceuticals Inc.	da0fe4da-a4f3-4aa8-84f4-4d31c5cbdb0e	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: CHLORTHALIDONE generic name: CHLORTHALIDONE
Thalitone	CHLORTHALIDONE	Casper Pharma LLC	bc5a0299-115b-4e60-bb3f-c75a95c51c15	2026-06-25	Warnings, Adverse reactions	Name fallback generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	PD-Rx Pharmaceuticals, Inc.	bb7112ae-3a37-4525-8c7f-c0f4100ffc0a	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Amneal Pharmaceuticals LLC	c4c1bfe5-b5c8-43c0-9428-62337095b2bd	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	bf09d68f-af7a-4057-92f1-13f1ef85d532	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	REMEDYREPACK INC.	7d8e26e6-7314-4799-b137-934926d343b0	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Umedica Laboratories USA Inc.	645734ab-d6aa-4368-9a5a-b550e2717770	2026-04-26	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
CHLORTHALIDONE	CHLORTHALIDONE	Bryant Ranch Prepack	f46fd743-3661-41b7-b12d-30d96692f0ee	2026-04-20	Warnings, Adverse reactions	Name fallback brand name: CHLORTHALIDONE generic name: CHLORTHALIDONE
CHLORTHALIDONE	CHLORTHALIDONE	REMEDYREPACK INC.	0baac2aa-06c4-489e-a3f9-fe9d20cf61a2	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: CHLORTHALIDONE generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Safecor Health, LLC	e0e316f6-96d1-4a89-a3b9-f4f0b4c9c833	2026-04-03	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Mylan Pharmaceuticals Inc.	15dd224a-87ad-48dc-80b1-e8382a452c4c	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Preferred Pharmaceuticals Inc.	180cc3c7-6ab7-481b-b860-b20d3599e53f	2026-03-27	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	da50019b-60ea-47b3-a355-4ab48efcbe3d	2026-03-20	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
CHLORTHALIDONE	CHLORTHALIDONE	REMEDYREPACK INC.	50936b5f-3eb8-4ff8-96b3-0aa4a8f77a98	2026-03-04	Warnings, Adverse reactions	Name fallback brand name: CHLORTHALIDONE generic name: CHLORTHALIDONE
CHLORTHALIDONE	CHLORTHALIDONE	AvPAK	972b801e-c4f2-4bd6-e053-2a95a90a53bb	2026-02-25	Warnings, Adverse reactions	Name fallback brand name: CHLORTHALIDONE generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	A-S Medication Solutions	583992c2-b789-4267-9a8f-c1ee5db3f29f	2026-02-19	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	a73613a3-914f-481a-8e40-8d782bcea03a	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE
Chlorthalidone	CHLORTHALIDONE	Preferred Pharmaceuticals Inc.	db169e46-9f6e-490e-856f-f60ec9a31980	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: Chlorthalidone generic name: CHLORTHALIDONE