aripiprazole 10 MG Oral Tablet
- RxCUI
- 349545
- RxNorm name
- aripiprazole 10 MG Oral Tablet
- Display name
- aripiprazole 10 MG Oral Tablet
- Full name
- aripiprazole 10 MG Oral Tablet
- Term type
- SCD
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:17
UNII Substances#
No records found.
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 |
|---|---|---|---|---|---|---|
| Aripiprazole | ARIPIPRAZOLE | REMEDYREPACK INC. | f713c38e-cc49-4243-96b9-32d5dbbcf9cb | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | 349545 |
| Aripiprazole | ARIPIPRAZOLE | Aurobindo Pharma Limited | 7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | 349545 |
| Aripiprazole | ARIPIPRAZOLE | REMEDYREPACK INC. | 119e3387-39a2-4fe5-904b-c2d008425c0a | 2026-07-22 | Boxed warning, Warnings, Adverse reactions | 349545 |
| Aripiprazole | ARIPIPRAZOLE | Coupler LLC | 56439ef6-a07e-34c9-e063-6294a90a77c3 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 349545 |
| Aripiprazole | ARIPIPRAZOLE | Bryant Ranch Prepack | 69af5199-f872-4298-8d09-035e2127d3d4 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 349545 |
| Aripiprazole | ARIPIPRAZOLE | Major Pharmaceuticals | 573c6bb6-941f-4413-8c23-826025385864 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 349545 |
| Aripiprazole | ARIPIPRAZOLE | Coupler LLC | 50214c47-2ea3-b373-e063-6394a90aad23 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | 349545 |
| Aripiprazole | ARIPIPRAZOLE | Bryant Ranch Prepack | ff8dc838-ca1a-49d3-8938-5ae645574a75 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 349545 |
| Aripiprazole | ARIPIPRAZOLE | Bryant Ranch Prepack | 1e8d889e-126b-4627-a2cc-34f2d35a5d67 | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | 349545 |
| Aripiprazole | ARIPIPRAZOLE | A-S Medication Solutions | 554db933-aa80-4685-bcd5-58c84571c19c | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | 349545 |
| Aripiprazole | ARIPIPRAZOLE | Quallent Pharmaceuticals Health LLC | 0e0d42ad-f4c6-4e30-adc2-ab1d122428ec | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | 349545 |
| Aripiprazole | ARIPIPRAZOLE | Dr.Reddys Laboratories Inc | 178f09f0-e08e-452b-b817-717c5c49e110 | 2025-10-24 | Boxed warning, Warnings, Adverse reactions | 349545 |
| Aripiprazole | ARIPIPRAZOLE | NuCare Pharmaceuticals, Inc. | 414b7fd2-6a63-af39-e063-6394a90a00b8 | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | 349545 |
| Aripiprazole | ARIPIPRAZOLE | Ajanta Pharma USA Inc. | d0f910b5-adef-4a93-9369-70f1ed541503 | 2025-10-10 | Boxed warning, Warnings, Adverse reactions | 349545 |
| ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | 85cc7d25-414b-4b6f-a03a-48af908a16a1 | 2025-10-06 | Boxed warning, Warnings, Adverse reactions | 349545 |
| Aripiprazole | ARIPIPRAZOLE | Ascend Laboratories, LLC | c7040fef-96a7-4429-9a8e-ec3ab17a8019 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 349545 |
| Aripiprazole | ARIPIPRAZOLE | AvPAK | 7df4c83e-13d8-25b1-57eb-08d26ba03565 | 2025-08-26 | Boxed warning, Warnings, Adverse reactions | 349545 |
| Aripiprazole | ARIPIPRAZOLE | American Health Packaging | 80e079f0-faf5-4c0c-b1a8-9bc3cc2cde00 | 2025-08-13 | Boxed warning, Warnings, Adverse reactions | 349545 |
| aripiprazole | ARIPIPRAZOLE | Proficient Rx LP | a3c0be94-c6c0-47e2-892f-c51f100fb3a3 | 2025-08-01 | Boxed warning, Warnings, Adverse reactions | 349545 |
| Aripiprazole | ARIPIPRAZOLE | Alembic Pharmaceuticals Inc. | a10a5427-58b1-42dd-964c-3f8c78770534 | 2025-06-25 | Boxed warning, Warnings, Adverse reactions | 349545 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 1e8d889e-126b-4627-a2cc-34f2d35a5d67 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 105 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20260128 |
| b62837db-1949-4dba-9e2f-714a9f136f5a | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 105 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20241029 |
| 69af5199-f872-4298-8d09-035e2127d3d4 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 102 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20240403 |
| ff8dc838-ca1a-49d3-8938-5ae645574a75 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 101 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20260305 |
| c040bd1d-45b7-49f2-93ea-aed7220b30ac | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 73 | These highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY. ABILIFY ® (aripiprazole) Tablets, for oral use Initial U.S. Approval: 2002 | 20250129 |
| c7040fef-96a7-4429-9a8e-ec3ab17a8019 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 26 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20251001 |
| 06dda03f-8481-46d6-af02-4f51e1a3a065 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 25 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20250220 |
| d0f910b5-adef-4a93-9369-70f1ed541503 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 20 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20251010 |
| a10a5427-58b1-42dd-964c-3f8c78770534 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 19 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval : 2002 | 20250625 |
| 3988e66f-339c-451e-9f8a-9d0c0a2a381b | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 17 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20250328 |
| 7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 17 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20250311 |
| 2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 17 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval: 2002 | 20240202 |
| f713c38e-cc49-4243-96b9-32d5dbbcf9cb | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 15 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20260213 |
| 349b8a7b-5ada-4f5c-a269-a86806c6b520 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 13 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20250220 |
| 85cc7d25-414b-4b6f-a03a-48af908a16a1 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 12 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE Tablets, for oral use Initial U.S. Approval: 2002 | 20251006 |
| 80e079f0-faf5-4c0c-b1a8-9bc3cc2cde00 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 9 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval: 2002 | 20250813 |
| ab4245a1-71f7-45be-a2ef-b0636ed3cc20 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 9 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20250324 |
| 95954ba3-e838-4dd7-aef1-c51ac6aff76b | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 8 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.’s ABILIFY ® (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20200506 |
| 554db933-aa80-4685-bcd5-58c84571c19c | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 7 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20260106 |
| 4bcfd5a7-bec7-4426-9314-17daaf715cad | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 7 | These highlights do not include all the information needed to use ARIPIPRAZOLE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE ORALLY DISINTEGRATING TABLETS. ARIPIPRAZOLE orally disintegrating tablets Initial U.S. Approval: 2002 | 20241113 |
| 0aa7e178-456a-4942-93aa-9ec18a58939f | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 7 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20200616 |
| 7df4c83e-13d8-25b1-57eb-08d26ba03565 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 6 | Aripiprazole Tablets Rx only HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval: 2002 | 20250826 |
| fbb3ac69-8dba-42df-8d6d-ef3d79241edb | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 6 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20250103 |
| 686d0088-ac61-41df-8909-ae12f7957644 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 6 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20230418 |
| 119e3387-39a2-4fe5-904b-c2d008425c0a | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 5 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval : 2002 | 20260203 |
| 178f09f0-e08e-452b-b817-717c5c49e110 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 5 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20251024 |
| 13339e7f-a8b4-430d-b623-47372de98348 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 5 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20240605 |
| 573c6bb6-941f-4413-8c23-826025385864 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 4 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20260106 |
| 0e0d42ad-f4c6-4e30-adc2-ab1d122428ec | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 4 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20251204 |
| 0a6fa113-6bb2-4f88-af07-ce0914c98ff2 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 3 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval: 2002 | 20230616 |
| 793fc904-2f11-4f97-a0ac-4d6910cac0f9 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 3 | These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002 | 20230127 |
| fcea91c3-e428-8991-e053-6394a90a099d | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 2 | Aripiprazole | 20250122 |
| f87dbfe4-5417-47c9-a97f-d246cfc10023 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 2 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval: 2002 | 20230830 |
| dd45a23a-08eb-055b-e053-2a95a90a14ac | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 2 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20230714 |
| a7d9d5d1-25ba-4f4e-a990-398c0bf09c7e | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 2 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002 | 20230220 |
| b284b294-40a0-4ccd-b7b7-b61267cd4e76 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 2 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval: 2002 | 20230116 |
| 705190bf-9f9d-4183-a56b-4eeafeacde59 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 2 | These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval: 2002 | 20181228 |
| bb777ae3-e177-4fcd-91c6-1b0886647616 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 2 | These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002 | 20160111 |
| 231e2433-31fe-4612-80f0-ba00dee3b26a | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 1 | These highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY. ABILIFY ® (aripiprazole) Tablets ABILIFY DISCMELT ® (aripiprazole) Orally Disintegrating Tablets ABILIFY ® (aripiprazole) Oral Solution ABILIFY ® (aripiprazole) Injection FOR INTRAMUSCULAR USE ONLY Initial U.S. Approval: 2002 | 20110217 |
| 217e52b5-3a7b-4bbe-af3c-b18de7d426c3 | ARIPiprazole 10 MG Oral Tablet [PSN] · aripiprazole 10 MG Oral Tablet [SCD] | 2 | 1 | These highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY. ABILIFY ® (aripiprazole) Tablets ABILIFY DISCMELT ® (aripiprazole) Orally Disintegrating Tablets ABILIFY ® (aripiprazole) Oral Solution ABILIFY ® (aripiprazole) Injection FOR INTRAMUSCULAR USE ONLY Initial U.S. Approval: 2002 | 20100831 |