risperiDONE 1 MG in 1 mL Oral Solution
- RxCUI
- 199387
- RxNorm name
- risperiDONE 1 MG in 1 mL Oral Solution
- Display name
- risperiDONE 1 MG in 1 mL Oral Solution
- Full name
- risperiDONE 1 MG in 1 mL Oral Solution
- Term type
- PSN
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:38:54
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 |
|---|---|---|---|---|---|---|
| Risperidone | RISPERIDONE | ATLANTIC BIOLOGICALS CORP. | dc8c6638-f487-49df-a265-78caa93e43d8 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 199387 |
| Risperidone | RISPERIDONE | ANI Pharmaceuticals, Inc. | 1f47ec91-602f-4fba-8f7e-a5698760b655 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 199387 |
| Risperidone | RISPERIDONE | Janssen Pharmaceutical, Inc. | 701e1cd8-2868-4d29-85a9-a2212c88165f | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | 199387 |
| RISPERDAL | RISPERIDONE | Janssen Pharmaceuticals, Inc. | 7e117c7e-02fc-4343-92a1-230061dfc5e0 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | 199387 |
| Risperidone | RISPERIDONE | REMEDYREPACK INC. | 8a4158fe-37d4-4c97-9c44-1c3489fe2a9f | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | 199387 |
| Risperidone | RISPERIDONE | REMEDYREPACK INC. | ab1cf6fd-9932-47fc-8736-476cc53a13fa | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | 199387 |
| Risperidone | RISPERIDONE | Bryant Ranch Prepack | 4604052d-dbda-4535-b7b8-1bd72a129aca | 2025-07-29 | Boxed warning, Warnings, Adverse reactions | 199387 |
| Risperidone | RISPERIDONE | Cranbury Pharmaceuticals, LLC | a0a21bec-68f0-444e-a611-d0602859410c | 2025-05-05 | Boxed warning, Warnings, Adverse reactions | 199387 |
| Risperidone | RISPERIDONE | Bryant Ranch Prepack | 3cc027f0-3462-4a2f-925b-d8a529bcb3c3 | 2025-03-21 | Boxed warning, Warnings, Adverse reactions | 199387 |
| RISPERIDONE | RISPERIDONE | Aurobindo Pharma Limited | c4582bdf-5eda-438c-98b4-0517500501e8 | 2025-03-04 | Boxed warning, Warnings, Adverse reactions | 199387 |
| Risperidone | RISPERIDONE | Amneal Pharmaceuticals LLC | bc55f60a-8121-44bb-bdfc-1d311879ba4f | 2025-02-12 | Boxed warning, Warnings, Adverse reactions | 199387 |
| RISPERIDONE | RISPERIDONE | Chartwell RX, LLC | 66390528-7517-452a-ae76-4338ec7db3ae | 2023-10-06 | Boxed warning, Warnings, Adverse reactions | 199387 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm string | TTY | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 3cc027f0-3462-4a2f-925b-d8a529bcb3c3 | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 104 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION, USP. RISPERIDONE Oral Solution, USP Initial U.S. Approval: 1993 | 20250321 |
| 3cc027f0-3462-4a2f-925b-d8a529bcb3c3 | risperidone 1 MG per 1 ML Oral Solution | SY | 104 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION, USP. RISPERIDONE Oral Solution, USP Initial U.S. Approval: 1993 | 20250321 |
| 3cc027f0-3462-4a2f-925b-d8a529bcb3c3 | risperidone 1 MG/ML Oral Solution | SCD | 104 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION, USP. RISPERIDONE Oral Solution, USP Initial U.S. Approval: 1993 | 20250321 |
| 4604052d-dbda-4535-b7b8-1bd72a129aca | risperidone 1 MG per 1 ML Oral Solution | SY | 100 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION, USP. RISPERIDONE Oral Solution, USP Initial U.S. Approval: 1993 | 20250729 |
| 4604052d-dbda-4535-b7b8-1bd72a129aca | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 100 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION, USP. RISPERIDONE Oral Solution, USP Initial U.S. Approval: 1993 | 20250729 |
| 4604052d-dbda-4535-b7b8-1bd72a129aca | risperidone 1 MG/ML Oral Solution | SCD | 100 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION, USP. RISPERIDONE Oral Solution, USP Initial U.S. Approval: 1993 | 20250729 |
| 701e1cd8-2868-4d29-85a9-a2212c88165f | risperidone 1 MG/ML Oral Solution | SCD | 33 | These highlights do not include all the information needed to use Risperidone Tablets, Oral Solution, and Orally Disintegrating Tablets safely and effectively. See full prescribing information for Risperidone Tablets, Oral Solution, and Orally Disintegrating Tablets. Risperidone Tablets, Risperidone Oral Solution, Risperidone Orally Disintegrating Tablets Initial U.S. Approval: 1993 | 20250731 |
| 701e1cd8-2868-4d29-85a9-a2212c88165f | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 33 | These highlights do not include all the information needed to use Risperidone Tablets, Oral Solution, and Orally Disintegrating Tablets safely and effectively. See full prescribing information for Risperidone Tablets, Oral Solution, and Orally Disintegrating Tablets. Risperidone Tablets, Risperidone Oral Solution, Risperidone Orally Disintegrating Tablets Initial U.S. Approval: 1993 | 20250731 |
| 701e1cd8-2868-4d29-85a9-a2212c88165f | risperidone 1 MG per 1 ML Oral Solution | SY | 33 | These highlights do not include all the information needed to use Risperidone Tablets, Oral Solution, and Orally Disintegrating Tablets safely and effectively. See full prescribing information for Risperidone Tablets, Oral Solution, and Orally Disintegrating Tablets. Risperidone Tablets, Risperidone Oral Solution, Risperidone Orally Disintegrating Tablets Initial U.S. Approval: 1993 | 20250731 |
| c4582bdf-5eda-438c-98b4-0517500501e8 | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 23 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution Initial U.S. Approval: 1993 | 20250304 |
| c4582bdf-5eda-438c-98b4-0517500501e8 | risperidone 1 MG/ML Oral Solution | SCD | 23 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution Initial U.S. Approval: 1993 | 20250304 |
| c4582bdf-5eda-438c-98b4-0517500501e8 | risperidone 1 MG per 1 ML Oral Solution | SY | 23 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution Initial U.S. Approval: 1993 | 20250304 |
| bc55f60a-8121-44bb-bdfc-1d311879ba4f | risperidone 1 MG/ML Oral Solution | SCD | 23 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution Initial U.S. Approval: 1993 | 20250212 |
| bc55f60a-8121-44bb-bdfc-1d311879ba4f | risperidone 1 MG per 1 ML Oral Solution | SY | 23 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution Initial U.S. Approval: 1993 | 20250212 |
| bc55f60a-8121-44bb-bdfc-1d311879ba4f | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 23 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution Initial U.S. Approval: 1993 | 20250212 |
| a0a21bec-68f0-444e-a611-d0602859410c | risperidone 1 MG per 1 ML Oral Solution | SY | 19 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION, USP. RISPERIDONE Oral Solution, USP Initial U.S. Approval: 1993 | 20250505 |
| a0a21bec-68f0-444e-a611-d0602859410c | risperidone 1 MG/ML Oral Solution | SCD | 19 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION, USP. RISPERIDONE Oral Solution, USP Initial U.S. Approval: 1993 | 20250505 |
| a0a21bec-68f0-444e-a611-d0602859410c | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 19 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION, USP. RISPERIDONE Oral Solution, USP Initial U.S. Approval: 1993 | 20250505 |
| b939e746-6b5f-ae82-c5f4-79cfdf6253ea | risperidone 1 MG/ML Oral Solution | SCD | 9 | These highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone. Risperidone Oral Solution USP Initial U.S. Approval: 1993 | 20111105 |
| b939e746-6b5f-ae82-c5f4-79cfdf6253ea | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 9 | These highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone. Risperidone Oral Solution USP Initial U.S. Approval: 1993 | 20111105 |
| b939e746-6b5f-ae82-c5f4-79cfdf6253ea | risperidone 1 MG per 1 ML Oral Solution | SY | 9 | These highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone. Risperidone Oral Solution USP Initial U.S. Approval: 1993 | 20111105 |
| 3c9836aa-81cc-4759-a5e9-bb061bbbacc2 | risperidone 1 MG per 1 ML Oral Solution | SY | 6 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution 1mg/mL Initial U.S. Approval: 1993 | 20170512 |
| 3c9836aa-81cc-4759-a5e9-bb061bbbacc2 | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 6 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution 1mg/mL Initial U.S. Approval: 1993 | 20170512 |
| 3c9836aa-81cc-4759-a5e9-bb061bbbacc2 | risperidone 1 MG/ML Oral Solution | SCD | 6 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution 1mg/mL Initial U.S. Approval: 1993 | 20170512 |
| 8a4158fe-37d4-4c97-9c44-1c3489fe2a9f | risperidone 1 MG/ML Oral Solution | SCD | 5 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION, USP. RISPERIDONE Oral Solution, USP Initial U.S. Approval: 1993 | 20260415 |
| 8a4158fe-37d4-4c97-9c44-1c3489fe2a9f | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 5 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION, USP. RISPERIDONE Oral Solution, USP Initial U.S. Approval: 1993 | 20260415 |
| 8a4158fe-37d4-4c97-9c44-1c3489fe2a9f | risperidone 1 MG per 1 ML Oral Solution | SY | 5 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION, USP. RISPERIDONE Oral Solution, USP Initial U.S. Approval: 1993 | 20260415 |
| ab1cf6fd-9932-47fc-8736-476cc53a13fa | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 5 | These highlights do not include all the information needed to use Risperidone Tablets, Oral Solution, and Orally Disintegrating Tablets safely and effectively. See full prescribing information for Risperidone Tablets, Oral Solution, and Orally Disintegrating Tablets. Risperidone Tablets, Risperidone Oral Solution, Risperidone Orally Disintegrating Tablets Initial U.S. Approval: 1993 | 20260415 |
| ab1cf6fd-9932-47fc-8736-476cc53a13fa | risperidone 1 MG/ML Oral Solution | SCD | 5 | These highlights do not include all the information needed to use Risperidone Tablets, Oral Solution, and Orally Disintegrating Tablets safely and effectively. See full prescribing information for Risperidone Tablets, Oral Solution, and Orally Disintegrating Tablets. Risperidone Tablets, Risperidone Oral Solution, Risperidone Orally Disintegrating Tablets Initial U.S. Approval: 1993 | 20260415 |
| ab1cf6fd-9932-47fc-8736-476cc53a13fa | risperidone 1 MG per 1 ML Oral Solution | SY | 5 | These highlights do not include all the information needed to use Risperidone Tablets, Oral Solution, and Orally Disintegrating Tablets safely and effectively. See full prescribing information for Risperidone Tablets, Oral Solution, and Orally Disintegrating Tablets. Risperidone Tablets, Risperidone Oral Solution, Risperidone Orally Disintegrating Tablets Initial U.S. Approval: 1993 | 20260415 |
| dc8c6638-f487-49df-a265-78caa93e43d8 | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 4 | RISPERIDONE ORAL SOLUTION These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION, USP. RISPERIDONE Oral Solution, USP Initial U.S. Approval: 1993 | 20260403 |
| dc8c6638-f487-49df-a265-78caa93e43d8 | risperidone 1 MG/ML Oral Solution | SCD | 4 | RISPERIDONE ORAL SOLUTION These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION, USP. RISPERIDONE Oral Solution, USP Initial U.S. Approval: 1993 | 20260403 |
| dc8c6638-f487-49df-a265-78caa93e43d8 | risperidone 1 MG per 1 ML Oral Solution | SY | 4 | RISPERIDONE ORAL SOLUTION These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION, USP. RISPERIDONE Oral Solution, USP Initial U.S. Approval: 1993 | 20260403 |
| 1f47ec91-602f-4fba-8f7e-a5698760b655 | risperidone 1 MG/ML Oral Solution | SCD | 2 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution Initial U.S. Approval: 1993 | 20260121 |
| 1f47ec91-602f-4fba-8f7e-a5698760b655 | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 2 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution Initial U.S. Approval: 1993 | 20260121 |
| 1f47ec91-602f-4fba-8f7e-a5698760b655 | risperidone 1 MG per 1 ML Oral Solution | SY | 2 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution Initial U.S. Approval: 1993 | 20260121 |
| 66390528-7517-452a-ae76-4338ec7db3ae | risperidone 1 MG per 1 ML Oral Solution | SY | 2 | These highlights do not include all the information needed to use Risperidone safely and effectively. See full prescribing information for Risperidone. Risperidone oral solution, USP Initial U.S. Approval: 1993 | 20231006 |
| 66390528-7517-452a-ae76-4338ec7db3ae | risperidone 1 MG/ML Oral Solution | SCD | 2 | These highlights do not include all the information needed to use Risperidone safely and effectively. See full prescribing information for Risperidone. Risperidone oral solution, USP Initial U.S. Approval: 1993 | 20231006 |
| 66390528-7517-452a-ae76-4338ec7db3ae | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 2 | These highlights do not include all the information needed to use Risperidone safely and effectively. See full prescribing information for Risperidone. Risperidone oral solution, USP Initial U.S. Approval: 1993 | 20231006 |
| dc3d0ad6-e739-4f6b-a696-49f553ac32a0 | risperidone 1 MG/ML Oral Solution | SCD | 2 | These highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone. Risperidone Oral Solution USP Initial U.S. Approval: 1993 | 20171228 |
| dc3d0ad6-e739-4f6b-a696-49f553ac32a0 | risperidone 1 MG per 1 ML Oral Solution | SY | 2 | These highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone. Risperidone Oral Solution USP Initial U.S. Approval: 1993 | 20171228 |
| dc3d0ad6-e739-4f6b-a696-49f553ac32a0 | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 2 | These highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone. Risperidone Oral Solution USP Initial U.S. Approval: 1993 | 20171228 |
| dae5ec58-85c1-4503-a6b8-56696dd1e6fc | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 2 | These highlights do not include all the information needed to use Risperidone safely and effectively. see full prescribing information for Risperidone. Risperidone (Risperidone) SOLUTION for ORAL use. Initial U.S. Approval: 1993 | 20110531 |
| dae5ec58-85c1-4503-a6b8-56696dd1e6fc | risperidone 1 MG/ML Oral Solution | SCD | 2 | These highlights do not include all the information needed to use Risperidone safely and effectively. see full prescribing information for Risperidone. Risperidone (Risperidone) SOLUTION for ORAL use. Initial U.S. Approval: 1993 | 20110531 |
| dae5ec58-85c1-4503-a6b8-56696dd1e6fc | risperidone 1 MG per 1 ML Oral Solution | SY | 2 | These highlights do not include all the information needed to use Risperidone safely and effectively. see full prescribing information for Risperidone. Risperidone (Risperidone) SOLUTION for ORAL use. Initial U.S. Approval: 1993 | 20110531 |
| 7d79e841-6316-450a-a44f-475d157eb1ec | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 1 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution 1 mg/mL Initial U.S. Approval: 1993 | 20181031 |
| 7d79e841-6316-450a-a44f-475d157eb1ec | risperidone 1 MG/ML Oral Solution | SCD | 1 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution 1 mg/mL Initial U.S. Approval: 1993 | 20181031 |
| 7d79e841-6316-450a-a44f-475d157eb1ec | risperidone 1 MG per 1 ML Oral Solution | SY | 1 | These highlights do not include all the information needed to use RISPERIDONE ORAL SOLUTION safely and effectively. See full prescribing information for RISPERIDONE ORAL SOLUTION. RISPERIDONE oral solution 1 mg/mL Initial U.S. Approval: 1993 | 20181031 |
| ea914046-6cc2-4c7b-b12b-76c31bb18def | risperidone 1 MG per 1 ML Oral Solution | SY | 1 | These highlights do not include all the information needed to use risperidone oral solution safely and effectively. See full prescribing information for risperidone oral solution. Risperidone Oral Solution for Oral use. Initial U.S. approval:1993 | 20101110 |
| ea914046-6cc2-4c7b-b12b-76c31bb18def | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 1 | These highlights do not include all the information needed to use risperidone oral solution safely and effectively. See full prescribing information for risperidone oral solution. Risperidone Oral Solution for Oral use. Initial U.S. approval:1993 | 20101110 |
| ea914046-6cc2-4c7b-b12b-76c31bb18def | risperidone 1 MG/ML Oral Solution | SCD | 1 | These highlights do not include all the information needed to use risperidone oral solution safely and effectively. See full prescribing information for risperidone oral solution. Risperidone Oral Solution for Oral use. Initial U.S. approval:1993 | 20101110 |
| f9e04064-6b9e-4209-8149-8761f29d1cec | risperiDONE 1 MG in 1 mL Oral Solution | PSN | 1 | These highlights do not include all the information needed to use risperidone oral solution safely and effectively. See full prescribing information for risperidone oral solution. Risperidone Oral Solution for Oral use. Initial U.S. approval:1993 | 20091014 |
| f9e04064-6b9e-4209-8149-8761f29d1cec | risperidone 1 MG per 1 ML Oral Solution | SY | 1 | These highlights do not include all the information needed to use risperidone oral solution safely and effectively. See full prescribing information for risperidone oral solution. Risperidone Oral Solution for Oral use. Initial U.S. approval:1993 | 20091014 |
| f9e04064-6b9e-4209-8149-8761f29d1cec | risperidone 1 MG/ML Oral Solution | SCD | 1 | These highlights do not include all the information needed to use risperidone oral solution safely and effectively. See full prescribing information for risperidone oral solution. Risperidone Oral Solution for Oral use. Initial U.S. approval:1993 | 20091014 |