Application 074203
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| 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 |
Orange Book products#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A074203-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | 1993-10-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074203-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | 1993-10-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074203-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | 1993-10-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074203-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | 1993-10-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074203-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | 1993-10-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074203-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | 1993-10-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074203-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | 1993-10-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074203-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | 1993-10-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074203-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | 1993-10-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074203-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | 1993-10-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074203-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | 1993-10-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074203-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | 1993-10-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074203-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | 1993-10-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074203-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | 1993-10-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074203-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | 1993-10-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074203-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | 1993-10-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074203-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | 1993-10-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074203-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | 1993-10-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074203-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | 1993-10-31 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074203-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | 1993-10-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074203-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | 1993-10-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074203-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | 1993-10-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074203-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | 1993-10-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074203-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | 1993-10-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074203-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | 1993-10-31 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074203-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | 1993-10-31 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074203-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | 1993-10-31 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074203-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | 1993-10-31 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074203-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | 1993-10-31 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074203-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | 1993-10-31 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074203-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | 1993-10-31 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074203-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | 1993-10-31 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074203-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | 1993-10-31 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074203-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | 1993-10-31 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074203-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | 1993-10-31 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074203-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | 1993-10-31 | 4b0b4de00fa7… | ||
| 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… |
Observed Orange Book normalized TE history#
| 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Atenolol and Chlorthalidone | ATENOLOL AND CHLORTHALIDONE | Preferred Pharmaceuticals Inc. | c58e12ad-d705-4643-91ac-ff079e9eb28e | 2026-07-16 | Warnings, Adverse reactions | Atenolol and Chlorthalidone |
| Atenolol and Chlorthalidone | ATENOLOL AND CHLORTHALIDONE | PD-Rx Pharmaceuticals, Inc. | 78b374f8-0e16-4c15-85c1-16609ac3aca2 | 2025-10-20 | Warnings, Adverse reactions | Atenolol and Chlorthalidone |
| Atenolol and Chlorthalidone | ATENOLOL AND CHLORTHALIDONE | REMEDYREPACK INC. | dfbd0160-f56a-41b9-a4ff-eb2df73b1e9b | 2025-09-25 | Warnings, Adverse reactions | Atenolol and Chlorthalidone |
| ATENOLOL AND CHLORTHALIDONE | ATENOLOL AND CHLORTHALIDONE TABLET | MARLEX PHARMACEUTICALS, INC | db22ff31-52f6-9024-e053-2995a90af8b3 | 2025-09-22 | Warnings, Adverse reactions | ATENOLOL AND CHLORTHALIDONE |
| Atenolol and Chlorthalidone | ATENOLOL AND CHLORTHALIDONE | Zydus Lifesciences Limited | a16d6010-a67d-4081-b2a3-ecef9f0f09ea | 2024-11-25 | Atenolol and Chlorthalidone | |
| Atenolol and Chlorthalidone | ATENOLOL AND CHLORTHALIDONE | ANI Pharmaceuticals, Inc. | 33690cc7-fffc-4620-888d-7f6453fe58c1 | 2024-03-14 | Warnings, Adverse reactions | Atenolol and Chlorthalidone |
| Atenolol and Chlorthalidone | ATENOLOL AND CHLORTHALIDONE | Actavis Pharma, Inc. | a6794dfa-adbb-491b-9d48-f89a44e866c5 | 2024-03-01 | Warnings, Adverse reactions | Atenolol and Chlorthalidone |
| Atenolol and Chlorthalidone | ATENOLOL AND CHLORTHALIDONE | Northstar Rx LLC. | 1494d5f7-8620-46da-8bca-69b76cd17635 | 2024-01-17 | Warnings, Adverse reactions | Atenolol and Chlorthalidone |
| Atenolol and Chlorthalidone | ATENOLOL AND CHLORTHALIDONE | Unichem Pharmaceuticals (USA), Inc. | a85d28c1-e812-4c12-aa67-136bff3610e5 | 2024-01-16 | Warnings, Adverse reactions | Atenolol and Chlorthalidone |
| Atenolol and Chlorthalidone | ATENOLOL AND CHLORTHALIDONE | Zydus Pharmaceuticals USA Inc. | 69131547-f554-4980-b54e-007afc2c696e | 2024-01-08 | Warnings, Adverse reactions | Atenolol and Chlorthalidone |
NDC Listings For This Application#
| 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 |