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 |
|---|---|---|---|---|---|---|---|---|---|
| 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… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A202884-003 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;25MG | TABLET / ORAL | 2013-06-03 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A202884-001 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 16MG;12.5MG | TABLET / ORAL | 2012-12-04 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A202884-002 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | 32MG;12.5MG | TABLET / ORAL | 2012-12-04 | c0c555d07b60… |
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 |