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SAPHRIS
SAPHRIS - 0052-0119-82 - (Asenapine Maleate)
Drug Information of SAPHRIS
| Product NDC: | 0052-0119 |
| 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) |
Labeler Information of SAPHRIS
| Product NDC: | 0052-0119 |
| Labeler Name: | Organon Pharmaceuticals USA |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022117 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090813 |
Package Information of SAPHRIS
| Package NDC: | 0052-0119-82 |
| Package Description: | 2 CASE in 1 CARTON (0052-0119-82) > 1 BLISTER PACK in 1 CASE > 10 TABLET in 1 BLISTER PACK |
NDC Information of SAPHRIS
| NDC Code | 0052-0119-82 |
| Proprietary Name | SAPHRIS |
| Package Description | 2 CASE in 1 CARTON (0052-0119-82) > 1 BLISTER PACK in 1 CASE > 10 TABLET in 1 BLISTER PACK |
| Product NDC | 0052-0119 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Asenapine Maleate |
| Dosage Form Name | TABLET |
| Route Name | SUBLINGUAL |
| Start Marketing Date | 20090813 |
| Marketing Category Name | NDA |
| Labeler Name | Organon Pharmaceuticals USA |
| Substance Name | ASENAPINE MALEATE |
| Strength Number | 10 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Atypical Antipsychotic [EPC] |
