Application 074203

Type: ANDA
Sponsor: MYLAN

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 44.

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
A074203-001	ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	50MG;25MG	TABLET / ORAL			1993-10-31
A074203-002	ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE	100MG;25MG	TABLET / ORAL			1993-10-31

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 2 of 3 · 88 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
2019-12-13 00:20 UTC	2019-12	A074203-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	1993-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074203-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	1993-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074203-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL		1993-10-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074203-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL		1993-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074203-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL		1993-10-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074203-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL		1993-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074203-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL		1993-10-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074203-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL		1993-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074203-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL		1993-10-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074203-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL		1993-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074203-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL		1993-10-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074203-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL		1993-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074203-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL		1993-10-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074203-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL		1993-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074203-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	1993-10-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074203-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	1993-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074203-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	1993-10-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074203-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	1993-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074203-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL	AB	1993-10-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074203-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL	AB	1993-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074203-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL		1993-10-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074203-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL		1993-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074203-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL		1993-10-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A074203-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL		1993-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074203-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL		1993-10-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A074203-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL		1993-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074203-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL		1993-10-31	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074203-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL		1993-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074203-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL		1993-10-31	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074203-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL		1993-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074203-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL		1993-10-31	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074203-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL		1993-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074203-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL		1993-10-31	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074203-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL		1993-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074203-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL		1993-10-31	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A074203-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL		1993-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074203-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL		1993-10-31	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A074203-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL		1993-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074203-001	ATENOLOL AND CHLORTHALIDONE	50MG;25MG	TABLET / ORAL		1993-10-31	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074203-002	ATENOLOL AND CHLORTHALIDONE	100MG;25MG	TABLET / ORAL		1993-10-31	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074203-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074203-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A074203-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074203-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074203-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074203-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074203-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074203-002	AB	1	`ea99ee380514…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol and Chlorthalidone	ATENOLOL AND CHLORTHALIDONE	REMEDYREPACK INC.	dfbd0160-f56a-41b9-a4ff-eb2df73b1e9b	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Atenolol and Chlorthalidone
Atenolol and Chlorthalidone	ATENOLOL AND CHLORTHALIDONE	Preferred Pharmaceuticals Inc.	c58e12ad-d705-4643-91ac-ff079e9eb28e	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Atenolol and Chlorthalidone
Atenolol and Chlorthalidone	ATENOLOL AND CHLORTHALIDONE	PD-Rx Pharmaceuticals, Inc.	78b374f8-0e16-4c15-85c1-16609ac3aca2	2025-10-20	Warnings, Adverse reactions	Name fallback brand name: Atenolol and Chlorthalidone
ATENOLOL AND CHLORTHALIDONE	ATENOLOL AND CHLORTHALIDONE TABLET	MARLEX PHARMACEUTICALS, INC	db22ff31-52f6-9024-e053-2995a90af8b3	2025-09-22	Warnings, Adverse reactions	Name fallback brand name: ATENOLOL AND CHLORTHALIDONE
Atenolol and Chlorthalidone	ATENOLOL AND CHLORTHALIDONE	ANI Pharmaceuticals, Inc.	33690cc7-fffc-4620-888d-7f6453fe58c1	2024-03-14	Warnings, Adverse reactions	Name fallback brand name: Atenolol and Chlorthalidone
Atenolol and Chlorthalidone	ATENOLOL AND CHLORTHALIDONE	Actavis Pharma, Inc.	a6794dfa-adbb-491b-9d48-f89a44e866c5	2024-03-01	Warnings, Adverse reactions	Name fallback brand name: Atenolol and Chlorthalidone
Atenolol and Chlorthalidone	ATENOLOL AND CHLORTHALIDONE	Unichem Pharmaceuticals (USA), Inc.	a85d28c1-e812-4c12-aa67-136bff3610e5	2024-01-16	Warnings, Adverse reactions	Name fallback brand name: Atenolol and Chlorthalidone

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-2063	Atenolol and Chlorthalidone	atenolol and chlorthalidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2064	Atenolol and Chlorthalidone	atenolol and chlorthalidone	Mylan Pharmaceuticals Inc.	ANDA	Current
43353-985	Atenolol and Chlorthalidone	atenolol and chlorthalidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current