SAPHRIS - 0052-0118-82 - (Asenapine Maleate)

Alphabetical Index


Drug Information of SAPHRIS

Product NDC: 0052-0118
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)

Labeler Information of SAPHRIS

Product NDC: 0052-0118
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: 0052-0118-82
Package Description: 2 CASE in 1 CARTON (0052-0118-82) > 1 BLISTER PACK in 1 CASE > 10 TABLET in 1 BLISTER PACK

NDC Information of SAPHRIS

NDC Code 0052-0118-82
Proprietary Name SAPHRIS
Package Description 2 CASE in 1 CARTON (0052-0118-82) > 1 BLISTER PACK in 1 CASE > 10 TABLET in 1 BLISTER PACK
Product NDC 0052-0118
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 5
Strength Unit mg/1
Pharmaceutical Classes Atypical Antipsychotic [EPC]

Complete Information of SAPHRIS


General Information