Application 207813

Type: ANDA
Sponsor: ZYDUS PHARMS

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
A207813-001	CHLORTHALIDONE	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2019-05-10
A207813-002	CHLORTHALIDONE	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2019-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207813-001	AB
A207813-002	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 3 · 82 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	A207813-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207813-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207813-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207813-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207813-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207813-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207813-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207813-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207813-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207813-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207813-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207813-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207813-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207813-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207813-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-05-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207813-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207813-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-05-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207813-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207813-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-05-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207813-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207813-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-05-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207813-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207813-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-05-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207813-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-05-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207813-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-05-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207813-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-05-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207813-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-05-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207813-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-05-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207813-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-05-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207813-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-05-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207813-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-05-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207813-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-05-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207813-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-05-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207813-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-05-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207813-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-05-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207813-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-05-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207813-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-05-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207813-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-05-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207813-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-05-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207813-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-05-10	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A207813-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207813-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207813-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207813-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207813-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207813-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207813-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207813-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207813-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207813-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207813-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207813-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207813-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207813-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207813-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207813-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207813-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207813-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207813-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207813-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207813-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207813-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207813-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207813-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207813-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207813-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207813-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207813-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207813-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207813-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207813-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207813-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207813-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207813-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207813-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207813-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207813-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207813-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207813-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207813-002	AB	1	`782e0a99824c…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorthalidone	CHLORTHALIDONE	Zydus Lifesciences Limited	6b432c76-b171-4c29-abf4-6d357976e6ef	2024-11-26		Exact identifier application applno (ANDA): 207813 application number: ANDA207813 ndc (product): 70771-1369 ndc (product): 70771-1370
Chlorthalidone	CHLORTHALIDONE	A-S Medication Solutions	1b1ff6c9-2367-4446-87a6-be86c0efd8e1	2023-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207813 application number: ANDA207813
Chlorthalidone	CHLORTHALIDONE	A-S Medication Solutions	14f9e2c6-ceb0-4306-9936-ca109912de12	2023-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207813 application number: ANDA207813
Chlorthalidone	CHLORTHALIDONE	Northstar Rx LLC.	56635d7a-1fff-4d1f-bf2c-def4b1ad8208	2022-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207813 application number: ANDA207813 ndc (product): 16714-128 ndc (product): 16714-129
Chlorthalidone	CHLORTHALIDONE	Zydus Pharmaceuticals USA Inc.	ef8023a3-b2be-436e-9085-576781950665	2022-10-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207813 application number: ANDA207813 ndc (product): 68382-971 ndc (product): 68382-970

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-128	Chlorthalidone	Chlorthalidone	Northstar Rx LLC.	ANDA	Current
16714-128	Chlorthalidone	Chlorthalidone	Northstar Rx LLC.	ANDA	Current
16714-129	Chlorthalidone	Chlorthalidone	Northstar Rx LLC.	ANDA	Current
16714-129	Chlorthalidone	Chlorthalidone	Northstar Rx LLC.	ANDA	Current
68382-970	Chlorthalidone	Chlorthalidone	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-970	Chlorthalidone	Chlorthalidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-970	Chlorthalidone	Chlorthalidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-971	Chlorthalidone	Chlorthalidone	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-971	Chlorthalidone	Chlorthalidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-971	Chlorthalidone	Chlorthalidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1369	Chlorthalidone	Chlorthalidone	Cadila Healthcare Limited	ANDA	Current
70771-1369	Chlorthalidone	Chlorthalidone	Cadila Healthcare Limited	ANDA	Current
70771-1369	Chlorthalidone	Chlorthalidone	Zydus Lifesciences Limited	ANDA	Current
70771-1370	Chlorthalidone	Chlorthalidone	Cadila Healthcare Limited	ANDA	Current
70771-1370	Chlorthalidone	Chlorthalidone	Cadila Healthcare Limited	ANDA	Current
70771-1370	Chlorthalidone	Chlorthalidone	Zydus Lifesciences Limited	ANDA	Current