Application 202884
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 16MG;12.5MG | No | No |
| 002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 32MG;12.5MG | No | No |
| 003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 32MG;25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | ||
| A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | ||
| A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| Candesartan Cilexetil and Hydrochlorothiazide | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | ANI Pharmaceuticals, Inc. | bd8d318d-167a-4b26-935d-265dde3193de | 2025-12-22 | Boxed warning, Warnings, Adverse reactions | Candesartan Cilexetil and Hydrochlorothiazide |
| Candesartan Cilexetil and Hydrochlorothiazide | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | Macleods Pharmaceuticals Limited | 76630807-9717-44be-946d-756038cf677e | 2025-05-15 | Boxed warning, Warnings, Adverse reactions | Candesartan Cilexetil and Hydrochlorothiazide |
| candesartan cilexetil and hydrochlorothiazide | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | Zydus Lifesciences Limited | cb328bc1-5738-4620-b2b3-442e98388a86 | 2024-11-11 | candesartan cilexetil and hydrochlorothiazide | |
| candesartan cilexetil and hydrochlorothiazide | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | Solco Healthcare LLC | 543b9806-ccfa-4144-a2a2-d0e35eaceeee | 2021-05-21 | Boxed warning, Warnings, Adverse reactions | candesartan cilexetil and hydrochlorothiazide |
| Candesartan Cilexetil and Hydrochlorothiazide | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | Mylan Pharmaceuticals Inc. | f3c4f7ed-e667-4528-a675-b032c2a4425d | 2020-08-15 | Boxed warning, Warnings, Adverse reactions | Candesartan Cilexetil and Hydrochlorothiazide |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32332 | ORIG | 2012-12-06 |