| Product NDC: | 16590-936 |
| Proprietary Name: | SAPHRIS |
| Non Proprietary Name: | ASENAPINE MALEATE |
| Active Ingredient(s): | 10 mg/1 & nbsp; ASENAPINE MALEATE |
| Administration Route(s): | SUBLINGUAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 16590-936 |
| Labeler Name: | STAT RX USA LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022117 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090814 |
| Package NDC: | 16590-936-60 |
| Package Description: | 6 BLISTER PACK in 1 CARTON (16590-936-60) > 10 TABLET in 1 BLISTER PACK |
| NDC Code | 16590-936-60 |
| Proprietary Name | SAPHRIS |
| Package Description | 6 BLISTER PACK in 1 CARTON (16590-936-60) > 10 TABLET in 1 BLISTER PACK |
| Product NDC | 16590-936 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | ASENAPINE MALEATE |
| Dosage Form Name | TABLET |
| Route Name | SUBLINGUAL |
| Start Marketing Date | 20090814 |
| Marketing Category Name | NDA |
| Labeler Name | STAT RX USA LLC |
| Substance Name | ASENAPINE MALEATE |
| Strength Number | 10 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Atypical Antipsychotic [EPC] |