Application 202079
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | TABLET;ORAL | 4MG | No | No |
| 002 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | TABLET;ORAL | 8MG | No | No |
| 003 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | TABLET;ORAL | 16MG | No | No |
| 004 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | TABLET;ORAL | 32MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202079-001 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 4MG | TABLET / ORAL | 2014-01-10 | ||
| A202079-002 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 8MG | TABLET / ORAL | 2014-01-10 | ||
| A202079-003 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 16MG | TABLET / ORAL | 2014-01-10 | ||
| A202079-004 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | 32MG | TABLET / ORAL | 2014-01-10 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202079-001 | CANDESARTAN CILEXETIL | 4MG | TABLET / ORAL | 2014-01-10 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202079-002 | CANDESARTAN CILEXETIL | 8MG | TABLET / ORAL | 2014-01-10 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202079-003 | CANDESARTAN CILEXETIL | 16MG | TABLET / ORAL | 2014-01-10 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202079-004 | CANDESARTAN CILEXETIL | 32MG | TABLET / ORAL | 2014-01-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202079-001 | CANDESARTAN CILEXETIL | 4MG | TABLET / ORAL | 2014-01-10 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202079-002 | CANDESARTAN CILEXETIL | 8MG | TABLET / ORAL | 2014-01-10 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202079-003 | CANDESARTAN CILEXETIL | 16MG | TABLET / ORAL | 2014-01-10 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202079-004 | CANDESARTAN CILEXETIL | 32MG | TABLET / ORAL | 2014-01-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202079-001 | CANDESARTAN CILEXETIL | 4MG | TABLET / ORAL | 2014-01-10 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202079-002 | CANDESARTAN CILEXETIL | 8MG | TABLET / ORAL | 2014-01-10 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202079-003 | CANDESARTAN CILEXETIL | 16MG | TABLET / ORAL | 2014-01-10 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202079-004 | CANDESARTAN CILEXETIL | 32MG | TABLET / ORAL | 2014-01-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202079-001 | CANDESARTAN CILEXETIL | 4MG | TABLET / ORAL | 2014-01-10 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202079-002 | CANDESARTAN CILEXETIL | 8MG | TABLET / ORAL | 2014-01-10 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202079-003 | CANDESARTAN CILEXETIL | 16MG | TABLET / ORAL | 2014-01-10 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202079-004 | CANDESARTAN CILEXETIL | 32MG | TABLET / ORAL | 2014-01-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202079-001 | CANDESARTAN CILEXETIL | 4MG | TABLET / ORAL | 2014-01-10 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202079-002 | CANDESARTAN CILEXETIL | 8MG | TABLET / ORAL | 2014-01-10 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202079-003 | CANDESARTAN CILEXETIL | 16MG | TABLET / ORAL | 2014-01-10 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202079-004 | CANDESARTAN CILEXETIL | 32MG | TABLET / ORAL | 2014-01-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202079-001 | CANDESARTAN CILEXETIL | 4MG | TABLET / ORAL | 2014-01-10 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202079-002 | CANDESARTAN CILEXETIL | 8MG | TABLET / ORAL | 2014-01-10 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202079-003 | CANDESARTAN CILEXETIL | 16MG | TABLET / ORAL | 2014-01-10 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202079-004 | CANDESARTAN CILEXETIL | 32MG | TABLET / ORAL | 2014-01-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202079-001 | CANDESARTAN CILEXETIL | 4MG | TABLET / ORAL | 2014-01-10 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202079-002 | CANDESARTAN CILEXETIL | 8MG | TABLET / ORAL | 2014-01-10 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202079-003 | CANDESARTAN CILEXETIL | 16MG | TABLET / ORAL | 2014-01-10 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202079-004 | CANDESARTAN CILEXETIL | 32MG | TABLET / ORAL | 2014-01-10 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202079-001 | CANDESARTAN CILEXETIL | 4MG | TABLET / ORAL | 2014-01-10 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202079-002 | CANDESARTAN CILEXETIL | 8MG | TABLET / ORAL | 2014-01-10 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202079-003 | CANDESARTAN CILEXETIL | 16MG | TABLET / ORAL | 2014-01-10 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202079-004 | CANDESARTAN CILEXETIL | 32MG | TABLET / ORAL | 2014-01-10 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202079-001 | CANDESARTAN CILEXETIL | 4MG | TABLET / ORAL | 2014-01-10 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202079-002 | CANDESARTAN CILEXETIL | 8MG | TABLET / ORAL | 2014-01-10 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202079-003 | CANDESARTAN CILEXETIL | 16MG | TABLET / ORAL | 2014-01-10 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202079-004 | CANDESARTAN CILEXETIL | 32MG | TABLET / ORAL | 2014-01-10 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202079-001 | CANDESARTAN CILEXETIL | 4MG | TABLET / ORAL | 2014-01-10 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202079-002 | CANDESARTAN CILEXETIL | 8MG | TABLET / ORAL | 2014-01-10 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202079-003 | CANDESARTAN CILEXETIL | 16MG | TABLET / ORAL | 2014-01-10 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202079-004 | CANDESARTAN CILEXETIL | 32MG | TABLET / ORAL | 2014-01-10 | 4b0b4de00fa7… |
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 | CANDESARTAN CILEXETIL | Viona Pharmaceuticals Inc | 9da86c48-5911-4512-8c71-eca4a6418cf6 | 2026-09-07 | Boxed warning, Warnings, Adverse reactions | Candesartan cilexetil CANDESARTAN CILEXETIL |
| Candesartan cilexetil | CANDESARTAN CILEXETIL | Golden State Medical Supply, Inc. | 15601654-76da-04cf-e063-6394a90a2cb5 | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | Candesartan cilexetil CANDESARTAN CILEXETIL |
| Candesartan cilexetil | CANDESARTAN CILEXETIL | Zydus Lifesciences Limited | 26df3269-3682-4ce0-be81-8c029254b5a8 | 2025-12-24 | Candesartan cilexetil CANDESARTAN CILEXETIL | |
| ATACAND | CANDESARTAN CILEXETIL | ANI Pharmaceuticals, Inc. | 94a59260-d2b6-464a-b5b9-bbc599e57e10 | 2025-12-22 | Boxed warning, Warnings, Adverse reactions | CANDESARTAN CILEXETIL |
| Candesartan cilexetil | CANDESARTAN CILEXETIL | ANI Pharmaceuticals, Inc. | 4621249c-1f44-4d95-8513-a1a2b1859e41 | 2025-12-22 | Boxed warning, Warnings, Adverse reactions | Candesartan cilexetil CANDESARTAN CILEXETIL |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Bryant Ranch Prepack | 9afc130e-a784-49fe-9772-27c492724f08 | 2023-09-25 | Boxed warning, Warnings, Adverse reactions | CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Limited | d5b43fa0-6678-4219-99f1-10d273d49baf | 2023-01-27 | Boxed warning, Warnings, Adverse reactions | CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Limited | d23fe59a-2ad6-4885-a0d8-2239048f05a3 | 2023-01-13 | Boxed warning, Warnings, Adverse reactions | CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Inc. | 0f2b2fa3-249b-4756-a3f1-3223a004d9cb | 2021-10-04 | Boxed warning, Warnings, Adverse reactions | CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL |
| CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | Alembic Pharmaceuticals Inc. | 8a515af5-bd53-43f1-b40a-aa0f332bc2ab | 2021-09-30 | Boxed warning, Warnings, Adverse reactions | CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL |
| candesartan cilexetil | CANDESARTAN CILEXETIL | Mylan Pharmaceuticals Inc. | 904b357e-97bf-475e-90a5-f0449f2a428e | 2021-05-12 | Boxed warning, Warnings, Adverse reactions | candesartan cilexetil CANDESARTAN CILEXETIL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.