lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet
- RxCUI
- 351261
- RxNorm name
- lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet
- Display name
- lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet
- Full name
- lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet
- Term type
- PSN
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:03
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 |
|---|---|---|---|---|---|---|
| Lansoprazole | LANSOPRAZOLE | Walgreen Company | a72f92cc-db49-40ef-a249-6b7c50dc8ef2 | 2026-02-28 | Warnings | 351261 |
| Prevacid | LANSOPRAZOLE | Takeda Pharmaceuticals America, Inc. | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 2025-07-08 | Warnings, Adverse reactions | 351261 |
| lansoprazole | LANSOPRAZOLE | Kroger Company | 4c0684b5-5c18-4ed5-8185-8b5d51dce3a0 | 2025-02-08 | Warnings | 351261 |
| Lansoprazole | LANSOPRAZOLE | CVS Pharmacy | 992a8f95-475c-4e57-90cc-9839c8678427 | 2025-02-08 | Warnings | 351261 |
| topcare Lansoprazole | LANSOPRAZOLE | Topco Associates LLC | ec5d6d5c-11e7-4932-a48f-fb72218ceccd | 2025-02-08 | Warnings | 351261 |
| Good Sense Lansoprazole | LANSOPRAZOLE | L. Perrigo Company | d86585b7-e146-4f04-9016-412b16e06f55 | 2025-01-29 | Warnings | 351261 |
| basic care lansoprazole | LANSOPRAZOLE | Amazon.com Services LLC | f39feec2-54fb-47d4-9b45-08f75e92117e | 2025-01-24 | Warnings | 351261 |
| LANSOPRAZOLE | LANSOPRAZOLE | Zydus Lifesciences Limited | 76ffd38e-bea8-45a0-b6bd-82f0043ce64d | 2024-11-30 | 351261 | |
| Lansoprazole | LANSOPRAZOLE | NorthStar Rx LLC | ac051296-6fe3-4ab5-a001-cc3e06199a22 | 2024-08-08 | Warnings, Adverse reactions | 351261 |
| Lansoprazole | LANSOPRAZOLE | Dr.Reddys Laboratories Inc | 656bc92a-1f95-047d-cd27-724073e63fe6 | 2024-06-11 | Warnings, Adverse reactions | 351261 |
| Lansoprazole | LANSOPRAZOLE | Aurobindo Pharma Limited | 1f2883d8-12db-40b7-9104-22a6690a22a7 | 2024-04-02 | Warnings, Adverse reactions | 351261 |
| Lansoprazole | LANSOPRAZOLE | Mylan Pharmaceuticals Inc. | 20ff347c-ca18-497b-948d-1145035f2ffc | 2024-03-11 | Warnings, Adverse reactions | 351261 |
| Lansoprazole | LANSOPRAZOLE | NorthStar Rx LLC | 4c7cc078-09de-f4fc-d111-1248f2261d17 | 2023-07-15 | Warnings, Adverse reactions | 351261 |
| equate lansoprazole | LANSOPRAZOLE | Wal-Mart Stores Inc | 89b91d5f-008c-4e9d-83e0-23b673b9c469 | 2022-12-07 | Warnings | 351261 |
| LANSOPRAZOLE | LANSOPRAZOLE | Zydus Pharmaceuticals USA Inc. | 9b3869ad-f2f7-4954-b75c-5c23b8951635 | 2022-08-22 | Warnings, Adverse reactions | 351261 |
| Lansoprazole | LANSOPRAZOLE | Teva Pharmaceuticals USA, Inc. | 6b8dd0e1-cd69-4f9a-887f-e42627b5d78e | 2022-04-29 | Warnings, Adverse reactions | 351261 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm string | TTY | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 71ba78cb-7e46-43eb-9425-fa130f537f84 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | SY | 45 | These highlights do not include all the information needed to use PREVACID and PREVACID SOLUTAB safely and effectively. See full prescribing information for PREVACID and PREVACID SOLUTAB. PREVACID (lansoprazole) delayed-release capsules, for oral use PREVACID SOLUTAB (lansoprazole) delayed-release orally disintegrating tablets Initial U.S. Approval: 1995 | 20250708 |
| 71ba78cb-7e46-43eb-9425-fa130f537f84 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 45 | These highlights do not include all the information needed to use PREVACID and PREVACID SOLUTAB safely and effectively. See full prescribing information for PREVACID and PREVACID SOLUTAB. PREVACID (lansoprazole) delayed-release capsules, for oral use PREVACID SOLUTAB (lansoprazole) delayed-release orally disintegrating tablets Initial U.S. Approval: 1995 | 20250708 |
| 71ba78cb-7e46-43eb-9425-fa130f537f84 | lansoprazole 15 MG Disintegrating Oral Tablet | SCD | 45 | These highlights do not include all the information needed to use PREVACID and PREVACID SOLUTAB safely and effectively. See full prescribing information for PREVACID and PREVACID SOLUTAB. PREVACID (lansoprazole) delayed-release capsules, for oral use PREVACID SOLUTAB (lansoprazole) delayed-release orally disintegrating tablets Initial U.S. Approval: 1995 | 20250708 |
| 6b8dd0e1-cd69-4f9a-887f-e42627b5d78e | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 14 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE delayed-release orally disintegrating tablets Initial U.S. Approval: 1995 | 20220429 |
| 6b8dd0e1-cd69-4f9a-887f-e42627b5d78e | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | SY | 14 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE delayed-release orally disintegrating tablets Initial U.S. Approval: 1995 | 20220429 |
| 6b8dd0e1-cd69-4f9a-887f-e42627b5d78e | lansoprazole 15 MG Disintegrating Oral Tablet | SCD | 14 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE delayed-release orally disintegrating tablets Initial U.S. Approval: 1995 | 20220429 |
| 656bc92a-1f95-047d-cd27-724073e63fe6 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | SY | 11 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE delayed-release orally disintegrating tablets, for oral use Initial U.S. Approval: 1995 | 20240611 |
| 656bc92a-1f95-047d-cd27-724073e63fe6 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 11 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE delayed-release orally disintegrating tablets, for oral use Initial U.S. Approval: 1995 | 20240611 |
| 656bc92a-1f95-047d-cd27-724073e63fe6 | lansoprazole 15 MG Disintegrating Oral Tablet | SCD | 11 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE delayed-release orally disintegrating tablets, for oral use Initial U.S. Approval: 1995 | 20240611 |
| a72f92cc-db49-40ef-a249-6b7c50dc8ef2 | lansoprazole 15 MG Disintegrating Oral Tablet | SCD | 6 | Walgreen Co. Lansoprazole Drug Facts | 20260228 |
| a72f92cc-db49-40ef-a249-6b7c50dc8ef2 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | SY | 6 | Walgreen Co. Lansoprazole Drug Facts | 20260228 |
| a72f92cc-db49-40ef-a249-6b7c50dc8ef2 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 6 | Walgreen Co. Lansoprazole Drug Facts | 20260228 |
| 992a8f95-475c-4e57-90cc-9839c8678427 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | SY | 6 | CVS Pharmacy, Inc. Lansoprazole Drug Facts | 20250208 |
| 992a8f95-475c-4e57-90cc-9839c8678427 | lansoprazole 15 MG Disintegrating Oral Tablet | SCD | 6 | CVS Pharmacy, Inc. Lansoprazole Drug Facts | 20250208 |
| 992a8f95-475c-4e57-90cc-9839c8678427 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 6 | CVS Pharmacy, Inc. Lansoprazole Drug Facts | 20250208 |
| 76ffd38e-bea8-45a0-b6bd-82f0043ce64d | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | SY | 6 | LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS | 20241130 |
| 76ffd38e-bea8-45a0-b6bd-82f0043ce64d | lansoprazole 15 MG Disintegrating Oral Tablet | SCD | 6 | LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS | 20241130 |
| 76ffd38e-bea8-45a0-b6bd-82f0043ce64d | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 6 | LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS | 20241130 |
| 9b3869ad-f2f7-4954-b75c-5c23b8951635 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | SY | 6 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE delayed-release orally disintegrating tablets, for oral use Initial U.S. Approval: 1995 | 20220822 |
| 9b3869ad-f2f7-4954-b75c-5c23b8951635 | lansoprazole 15 MG Disintegrating Oral Tablet | SCD | 6 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE delayed-release orally disintegrating tablets, for oral use Initial U.S. Approval: 1995 | 20220822 |
| 9b3869ad-f2f7-4954-b75c-5c23b8951635 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 6 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE delayed-release orally disintegrating tablets, for oral use Initial U.S. Approval: 1995 | 20220822 |
| 4c0684b5-5c18-4ed5-8185-8b5d51dce3a0 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 5 | Kroger Co. Lansoprazole Drug Facts | 20250208 |
| 4c0684b5-5c18-4ed5-8185-8b5d51dce3a0 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | SY | 5 | Kroger Co. Lansoprazole Drug Facts | 20250208 |
| 4c0684b5-5c18-4ed5-8185-8b5d51dce3a0 | lansoprazole 15 MG Disintegrating Oral Tablet | SCD | 5 | Kroger Co. Lansoprazole Drug Facts | 20250208 |
| d86585b7-e146-4f04-9016-412b16e06f55 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | SY | 5 | Perrigo Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Drug Facts | 20250129 |
| d86585b7-e146-4f04-9016-412b16e06f55 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 5 | Perrigo Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Drug Facts | 20250129 |
| d86585b7-e146-4f04-9016-412b16e06f55 | lansoprazole 15 MG Disintegrating Oral Tablet | SCD | 5 | Perrigo Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Drug Facts | 20250129 |
| 20ff347c-ca18-497b-948d-1145035f2ffc | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | SY | 5 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS . LANSOPRAZOLE delayed-release orally disintegrating tablets, for oral use Initial U.S. Approval: 1995 | 20240311 |
| 20ff347c-ca18-497b-948d-1145035f2ffc | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 5 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS . LANSOPRAZOLE delayed-release orally disintegrating tablets, for oral use Initial U.S. Approval: 1995 | 20240311 |
| 20ff347c-ca18-497b-948d-1145035f2ffc | lansoprazole 15 MG Disintegrating Oral Tablet | SCD | 5 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS . LANSOPRAZOLE delayed-release orally disintegrating tablets, for oral use Initial U.S. Approval: 1995 | 20240311 |
| ec5d6d5c-11e7-4932-a48f-fb72218ceccd | lansoprazole 15 MG Disintegrating Oral Tablet | SCD | 4 | Topco Associates LLC. Lansoprazole Drug Facts | 20250208 |
| ec5d6d5c-11e7-4932-a48f-fb72218ceccd | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 4 | Topco Associates LLC. Lansoprazole Drug Facts | 20250208 |
| ec5d6d5c-11e7-4932-a48f-fb72218ceccd | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | SY | 4 | Topco Associates LLC. Lansoprazole Drug Facts | 20250208 |
| 89b91d5f-008c-4e9d-83e0-23b673b9c469 | lansoprazole 15 MG Disintegrating Oral Tablet | SCD | 4 | Wal-Mart Lansoprazole Drug Facts | 20221207 |
| 89b91d5f-008c-4e9d-83e0-23b673b9c469 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 4 | Wal-Mart Lansoprazole Drug Facts | 20221207 |
| 89b91d5f-008c-4e9d-83e0-23b673b9c469 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | SY | 4 | Wal-Mart Lansoprazole Drug Facts | 20221207 |
| 4c7cc078-09de-f4fc-d111-1248f2261d17 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | SY | 3 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE delayed-release orally disintegrating tablets, for oral use Initial U.S. Approval: 1995 | 20230715 |
| 4c7cc078-09de-f4fc-d111-1248f2261d17 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 3 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE delayed-release orally disintegrating tablets, for oral use Initial U.S. Approval: 1995 | 20230715 |
| 4c7cc078-09de-f4fc-d111-1248f2261d17 | lansoprazole 15 MG Disintegrating Oral Tablet | SCD | 3 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE delayed-release orally disintegrating tablets, for oral use Initial U.S. Approval: 1995 | 20230715 |
| f39feec2-54fb-47d4-9b45-08f75e92117e | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | SY | 2 | Amazon Lansoprazole Drug Facts | 20250124 |
| f39feec2-54fb-47d4-9b45-08f75e92117e | lansoprazole 15 MG Disintegrating Oral Tablet | SCD | 2 | Amazon Lansoprazole Drug Facts | 20250124 |
| f39feec2-54fb-47d4-9b45-08f75e92117e | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 2 | Amazon Lansoprazole Drug Facts | 20250124 |
| 1f2883d8-12db-40b7-9104-22a6690a22a7 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 2 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE delayed-release orally disintegrating tablets Initial U.S. Approval: 1995 | 20240402 |
| 1f2883d8-12db-40b7-9104-22a6690a22a7 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | SY | 2 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE delayed-release orally disintegrating tablets Initial U.S. Approval: 1995 | 20240402 |
| 1f2883d8-12db-40b7-9104-22a6690a22a7 | lansoprazole 15 MG Disintegrating Oral Tablet | SCD | 2 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE delayed-release orally disintegrating tablets Initial U.S. Approval: 1995 | 20240402 |
| 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 2 | These highlights do not include all the information needed to use PREVACID safely and effectively. See full prescribing information for: PREVACID (lansoprazole) Delayed-Release Capsules PREVACID SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets For oral administration Initial U.S. Approval: 1995 | 20091030 |
| 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | lansoprazole 15 MG Disintegrating Oral Tablet | SCD | 2 | These highlights do not include all the information needed to use PREVACID safely and effectively. See full prescribing information for: PREVACID (lansoprazole) Delayed-Release Capsules PREVACID SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets For oral administration Initial U.S. Approval: 1995 | 20091030 |
| 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | SY | 2 | These highlights do not include all the information needed to use PREVACID safely and effectively. See full prescribing information for: PREVACID (lansoprazole) Delayed-Release Capsules PREVACID SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets For oral administration Initial U.S. Approval: 1995 | 20091030 |
| ac051296-6fe3-4ab5-a001-cc3e06199a22 | lansoprazole 15 MG Disintegrating Oral Tablet | SCD | 1 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE delayed-release orally disintegrating tablets Initial U.S. Approval: 1995 | 20240808 |
| ac051296-6fe3-4ab5-a001-cc3e06199a22 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | SY | 1 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE delayed-release orally disintegrating tablets Initial U.S. Approval: 1995 | 20240808 |
| ac051296-6fe3-4ab5-a001-cc3e06199a22 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 1 | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE delayed-release orally disintegrating tablets Initial U.S. Approval: 1995 | 20240808 |