Application 020838
- Type
- NDA
- Sponsor
- ANI PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ATACAND | CANDESARTAN CILEXETIL | TABLET;ORAL | 4MG | Yes | No |
| 002 | ATACAND | CANDESARTAN CILEXETIL | TABLET;ORAL | 8MG | Yes | No |
| 003 | ATACAND | CANDESARTAN CILEXETIL | TABLET;ORAL | 16MG | Yes | No |
| 004 | ATACAND | CANDESARTAN CILEXETIL | TABLET;ORAL | 32MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020838-001 | ATACAND | CANDESARTAN CILEXETIL | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 |
| N020838-002 | ATACAND | CANDESARTAN CILEXETIL | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 |
| N020838-003 | ATACAND | CANDESARTAN CILEXETIL | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 |
| N020838-004 | ATACAND | CANDESARTAN CILEXETIL | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020838-001 | AB |
| N020838-002 | AB |
| N020838-003 | AB |
| N020838-004 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020838-001 | ATACAND | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020838-002 | ATACAND | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020838-003 | ATACAND | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020838-004 | ATACAND | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020838-001 | ATACAND | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020838-002 | ATACAND | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020838-003 | ATACAND | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020838-004 | ATACAND | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020838-001 | ATACAND | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020838-002 | ATACAND | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020838-003 | ATACAND | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020838-004 | ATACAND | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020838-001 | ATACAND | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020838-002 | ATACAND | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020838-003 | ATACAND | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020838-004 | ATACAND | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020838-001 | ATACAND | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020838-002 | ATACAND | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020838-003 | ATACAND | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020838-004 | ATACAND | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020838-001 | ATACAND | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020838-002 | ATACAND | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020838-003 | ATACAND | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020838-004 | ATACAND | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020838-001 | ATACAND | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020838-002 | ATACAND | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020838-003 | ATACAND | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020838-004 | ATACAND | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020838-001 | ATACAND | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020838-002 | ATACAND | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020838-003 | ATACAND | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020838-004 | ATACAND | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020838-001 | ATACAND | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020838-002 | ATACAND | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020838-003 | ATACAND | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020838-004 | ATACAND | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020838-001 | ATACAND | 4MG | TABLET / ORAL | AB | RLD | 1998-06-04 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020838-002 | ATACAND | 8MG | TABLET / ORAL | AB | RLD | 1998-06-04 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020838-003 | ATACAND | 16MG | TABLET / ORAL | AB | RLD | 1998-06-04 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020838-004 | ATACAND | 32MG | TABLET / ORAL | AB | RLD, RS | 1998-06-04 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020838-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020838-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020838-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020838-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020838-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020838-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020838-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020838-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020838-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020838-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020838-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020838-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020838-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020838-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020838-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020838-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020838-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020838-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020838-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020838-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020838-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020838-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020838-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020838-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020838-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020838-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020838-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020838-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020838-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020838-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020838-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020838-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020838-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020838-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020838-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020838-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020838-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020838-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020838-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020838-004 | AB | 1 | d06236e962d9… |
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 | Golden State Medical Supply, Inc. | 15601654-76da-04cf-e063-6394a90a2cb5 | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | 020838 NDA020838 |
| ATACAND | CANDESARTAN CILEXETIL | ANI Pharmaceuticals, Inc. | 94a59260-d2b6-464a-b5b9-bbc599e57e10 | 2025-12-22 | Boxed warning, Warnings, Adverse reactions | 020838 NDA020838 62559-642 62559-641 62559-640 62559-643 |
| Candesartan cilexetil | CANDESARTAN CILEXETIL | ANI Pharmaceuticals, Inc. | 4621249c-1f44-4d95-8513-a1a2b1859e41 | 2025-12-22 | Boxed warning, Warnings, Adverse reactions | 020838 NDA020838 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0186-0004 | ATACAND | Candesartan cilexetil | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0186-0008 | ATACAND | Candesartan cilexetil | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0186-0016 | ATACAND | Candesartan cilexetil | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0186-0032 | ATACAND | Candesartan cilexetil | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 49884-658 | Candesartan cilexetil | Candesartan cilexetil | Par Pharmaceutical Inc. | NDA AUTHORIZED GENERIC | Current |
| 49884-658 | Candesartan cilexetil | Candesartan cilexetil | Par Pharmaceutical Inc. | NDA AUTHORIZED GENERIC | Current |
| 49884-658 | Candesartan cilexetil | Candesartan cilexetil | Par Pharmaceutical Inc. | NDA AUTHORIZED GENERIC | Current |
| 49884-659 | Candesartan cilexetil | Candesartan cilexetil | Par Pharmaceutical Inc. | NDA AUTHORIZED GENERIC | Current |
| 49884-659 | Candesartan cilexetil | Candesartan cilexetil | Par Pharmaceutical Inc. | NDA AUTHORIZED GENERIC | Current |
| 49884-659 | Candesartan cilexetil | Candesartan cilexetil | Par Pharmaceutical Inc. | NDA AUTHORIZED GENERIC | Current |
| 49884-660 | Candesartan cilexetil | Candesartan cilexetil | Par Pharmaceutical Inc. | NDA AUTHORIZED GENERIC | Current |
| 49884-660 | Candesartan cilexetil | Candesartan cilexetil | Par Pharmaceutical Inc. | NDA AUTHORIZED GENERIC | Current |
| 49884-660 | Candesartan cilexetil | Candesartan cilexetil | Par Pharmaceutical Inc. | NDA AUTHORIZED GENERIC | Current |
| 49884-661 | Candesartan cilexetil | Candesartan cilexetil | Par Pharmaceutical Inc. | NDA AUTHORIZED GENERIC | Current |
| 49884-661 | Candesartan cilexetil | Candesartan cilexetil | Par Pharmaceutical Inc. | NDA AUTHORIZED GENERIC | Current |
| 49884-661 | Candesartan cilexetil | Candesartan cilexetil | Par Pharmaceutical Inc. | NDA AUTHORIZED GENERIC | Current |
| 60687-119 | Candesartan cilexetil | Candesartan cilexetil | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 60687-119 | Candesartan cilexetil | Candesartan cilexetil | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 60687-119 | Candesartan cilexetil | Candesartan cilexetil | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 60687-119 | Candesartan cilexetil | Candesartan cilexetil | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 60687-130 | Candesartan cilexetil | Candesartan cilexetil | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 60687-130 | Candesartan cilexetil | Candesartan cilexetil | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 60687-130 | Candesartan cilexetil | Candesartan cilexetil | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 60687-130 | Candesartan cilexetil | Candesartan cilexetil | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 60687-241 | Candesartan cilexetil | Candesartan cilexetil | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 60687-241 | Candesartan cilexetil | Candesartan cilexetil | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 60687-241 | Candesartan cilexetil | Candesartan cilexetil | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 60687-241 | Candesartan cilexetil | Candesartan cilexetil | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 62559-640 | ATACAND | Candesartan Cilexetil | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-640 | ATACAND | Candesartan Cilexetil | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-640 | ATACAND | Candesartan Cilexetil | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-641 | ATACAND | Candesartan Cilexetil | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-641 | ATACAND | Candesartan Cilexetil | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-641 | ATACAND | Candesartan Cilexetil | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-642 | ATACAND | Candesartan Cilexetil | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-642 | ATACAND | Candesartan Cilexetil | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-642 | ATACAND | Candesartan Cilexetil | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-643 | ATACAND | Candesartan Cilexetil | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-643 | ATACAND | Candesartan Cilexetil | ANI Pharmaceuticals, Inc. | NDA | Current |
| 62559-643 | ATACAND | Candesartan Cilexetil | ANI Pharmaceuticals, Inc. | NDA | Current |
| 63629-2126 | Candesartan cilexetil | Candesartan cilexetil | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-2126 | Candesartan cilexetil | Candesartan cilexetil | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-2126 | Candesartan cilexetil | Candesartan cilexetil | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-2127 | Candesartan cilexetil | Candesartan cilexetil | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-2127 | Candesartan cilexetil | Candesartan cilexetil | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-2127 | Candesartan cilexetil | Candesartan cilexetil | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-3376 | ATACAND | Candesartan cilexetil | Bryant Ranch Prepack | NDA | Current |
| 63629-3376 | ATACAND | Candesartan cilexetil | Bryant Ranch Prepack | NDA | Current |
| 68151-4145 | ATACAND | Candesartan cilexetil | Carilion Materials Management | NDA | Current |
| 68151-4146 | ATACAND | Candesartan cilexetil | Carilion Materials Management | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63699 | SUPPL | 2020-06-25 |
| 63695 | SUPPL | 2020-06-25 |
| 13577 | SUPPL | 2016-02-11 |
| 3529 | SUPPL | 2016-02-11 |
| 26017 | SUPPL | 2015-02-10 |
| 13576 | SUPPL | 2015-02-09 |
| 26018 | SUPPL | 2013-04-30 |
| 35485 | SUPPL | 2013-04-29 |
| 3528 | SUPPL | 2012-05-02 |
| 35484 | SUPPL | 2012-05-01 |
| 13575 | SUPPL | 2012-04-17 |
| 3527 | SUPPL | 2012-04-16 |
| 44075 | ORIG | 2011-12-22 |
| 26016 | SUPPL | 2011-07-05 |
| 35483 | SUPPL | 2011-06-28 |
| 26015 | SUPPL | 2009-11-05 |
| 35482 | SUPPL | 2009-10-23 |
| 51279 | SUPPL | 2007-01-30 |
| 35481 | SUPPL | 2006-08-21 |
| 3526 | SUPPL | 2006-08-21 |
| 13573 | SUPPL | 2005-05-20 |
| 3524 | SUPPL | 2005-05-20 |
| 51278 | SUPPL | 2005-03-15 |
| 26014 | SUPPL | 2005-02-23 |
| 13574 | SUPPL | 2005-02-23 |
| 3525 | SUPPL | 2004-12-30 |
| 51277 | SUPPL | 2004-08-27 |
| 41744 | SUPPL | 2004-05-27 |
| 26013 | SUPPL | 2004-05-27 |
| 21001 | SUPPL | 2004-05-27 |
| 51275 | SUPPL | 2003-11-02 |
| 3523 | SUPPL | 2003-05-29 |
| 21000 | ORIG | 2003-05-22 |
| 51276 | SUPPL | 2003-01-08 |
| 35480 | SUPPL | 2002-09-13 |
| 26012 | SUPPL | 2002-09-13 |
| 51274 | SUPPL | 1999-03-15 |
| 35479 | ORIG | 1998-06-04 |
| 26011 | ORIG | 1998-06-04 |
| 63880 | ORIG | 1900-01-01 |
| 63879 | ORIG | 1900-01-01 |
| 63878 | ORIG | 1900-01-01 |
| 63877 | ORIG | 1900-01-01 |
| 63876 | ORIG | 1900-01-01 |
| 63875 | ORIG | 1900-01-01 |
| 54099 | ORIG | 1900-01-01 |
| 54098 | ORIG | 1900-01-01 |
| 54097 | ORIG | 1900-01-01 |