Application 210028

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	TABLET;ORAL	50MG;25MG	No	No
002	ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	TABLET;ORAL	100MG;25MG	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
A210028-001	ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB		2019-03-08
A210028-002	ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB		2019-03-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210028-001	AB
A210028-002	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	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210028-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	2019-03-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210028-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	2019-03-08	`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	A210028-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210028-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210028-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210028-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210028-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210028-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210028-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210028-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210028-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210028-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210028-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210028-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210028-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210028-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210028-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210028-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210028-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210028-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210028-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210028-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210028-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210028-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210028-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210028-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210028-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210028-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210028-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210028-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210028-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210028-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210028-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210028-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210028-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210028-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210028-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210028-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210028-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210028-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210028-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210028-002	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol and Chlorthalidone	ATENOLOL AND CHLORTHALIDONE	Zydus Lifesciences Limited	a16d6010-a67d-4081-b2a3-ecef9f0f09ea	2024-11-25		Exact identifier application applno (ANDA): 210028 application number: ANDA210028 ndc (product): 70771-1373 ndc (product): 70771-1372
Atenolol and Chlorthalidone	ATENOLOL AND CHLORTHALIDONE	Northstar Rx LLC.	1494d5f7-8620-46da-8bca-69b76cd17635	2024-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210028 application number: ANDA210028 ndc (product): 16714-937 ndc (product): 16714-936
Atenolol and Chlorthalidone	ATENOLOL AND CHLORTHALIDONE	Zydus Pharmaceuticals USA Inc.	69131547-f554-4980-b54e-007afc2c696e	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210028 application number: ANDA210028 ndc (product): 70710-1167 ndc (product): 70710-1168

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-936	Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	Northstar Rx LLC.	ANDA	Current
16714-936	Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	Northstar Rx LLC.	ANDA	Current
16714-937	Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	Northstar Rx LLC.	ANDA	Current
16714-937	Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	Northstar Rx LLC.	ANDA	Current
70518-2446	Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	REMEDYREPACK INC.	ANDA	Current
70518-2446	Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	REMEDYREPACK INC.	ANDA	Current
70518-2446	Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	REMEDYREPACK INC.	ANDA	Current
70710-1167	Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1167	Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1167	Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1168	Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1168	Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1168	Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70771-1372	Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	Zydus Lifesciences Limited	ANDA	Current
70771-1372	Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	Cadila Healthcare Limited	ANDA	Current
70771-1372	Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	Cadila Healthcare Limited	ANDA	Current
70771-1373	Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	Zydus Lifesciences Limited	ANDA	Current
70771-1373	Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	Cadila Healthcare Limited	ANDA	Current
70771-1373	Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	Cadila Healthcare Limited	ANDA	Current