Application 216262

Type: ANDA
Sponsor: ALEMBIC PHARMS 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
A216262-001	CHLORTHALIDONE	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2022-08-26
A216262-002	CHLORTHALIDONE	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2022-08-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216262-001	AB
A216262-002	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 · 54 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	A216262-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216262-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216262-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216262-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216262-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216262-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216262-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216262-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216262-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216262-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216262-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216262-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216262-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216262-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216262-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216262-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216262-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216262-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216262-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216262-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216262-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216262-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216262-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216262-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-08-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216262-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-08-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216262-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-08-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216262-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-08-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216262-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-08-26	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216262-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-08-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216262-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-08-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216262-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-08-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216262-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-08-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216262-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-08-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216262-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-08-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216262-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-08-26	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216262-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-08-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216262-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-08-26	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216262-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-08-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216262-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-08-26	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216262-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-08-26	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 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	A216262-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216262-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216262-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216262-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216262-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216262-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216262-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216262-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216262-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216262-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216262-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216262-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216262-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216262-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216262-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216262-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216262-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216262-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216262-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216262-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216262-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216262-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216262-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216262-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216262-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216262-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216262-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216262-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216262-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216262-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216262-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216262-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216262-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216262-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216262-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216262-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216262-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216262-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216262-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216262-002	AB	1	`a67488948f0b…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHLORTHALIDONE CHLORTHALIDONE	CHLORTHALIDONE	Alembic Pharmaceuticals Limited	1b98d1a1-9d3d-41d2-a5e9-744b851d30d4	2022-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216262 application number: ANDA216262 ndc (product): 46708-676 ndc (product): 46708-677
CHLORTHALIDONE CHLORTHALIDONE	CHLORTHALIDONE	Alembic Pharmaceuticals Inc.	a1043a72-8e64-49da-a7e4-eadee083022e	2022-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216262 application number: ANDA216262 ndc (product): 62332-676 ndc (product): 62332-677

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-676	CHLORTHALIDONE	CHLORTHALIDONE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-677	CHLORTHALIDONE	CHLORTHALIDONE	Alembic Pharmaceuticals Limited	ANDA	Current
62332-676	CHLORTHALIDONE	CHLORTHALIDONE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-677	CHLORTHALIDONE	CHLORTHALIDONE	Alembic Pharmaceuticals Inc.	ANDA	Current