Product NDC: | 0052-2139 |
Proprietary Name: | SAPHRIS |
Non Proprietary Name: | Asenapine Maleate |
Active Ingredient(s): | 5 mg/1 & nbsp; Asenapine Maleate |
Administration Route(s): | SUBLINGUAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0052-2139 |
Labeler Name: | Organon Pharmaceuticals USA |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022117 |
Marketing Category: | NDA |
Start Marketing Date: | 20100621 |
Package NDC: | 0052-2139-02 |
Package Description: | 2 CASE in 1 CARTON (0052-2139-02) > 1 BLISTER PACK in 1 CASE > 10 TABLET in 1 BLISTER PACK |
NDC Code | 0052-2139-02 |
Proprietary Name | SAPHRIS |
Package Description | 2 CASE in 1 CARTON (0052-2139-02) > 1 BLISTER PACK in 1 CASE > 10 TABLET in 1 BLISTER PACK |
Product NDC | 0052-2139 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Asenapine Maleate |
Dosage Form Name | TABLET |
Route Name | SUBLINGUAL |
Start Marketing Date | 20100621 |
Marketing Category Name | NDA |
Labeler Name | Organon Pharmaceuticals USA |
Substance Name | ASENAPINE MALEATE |
Strength Number | 5 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Atypical Antipsychotic [EPC] |