01 3Allergan Aesthetics
02 3Breckenridge Pharmaceutical
03 3Alembic Pharmaceuticals Limited
04 3Hisamitsu Pharmaceutical Co., Inc.
05 2Kwality Pharmaceuticals
06 2N.V. Organon Kloosterstraat -
07 2ORGANON CANADA INC.
08 8Organon
09 2Sigmapharm Laboratories, LLC
01 1Asenapina 10Mg 60 Units Sublingual Use
02 1Asenapina 5Mg 60 Units Sublingual Use
03 2SUBLINGUAL TABLET
04 3SYSTEM;TRANSDERMAL
05 2Subling Tabl
06 2Sublingvaltablett
07 2TABLET
08 11TABLET;SUBLINGUAL
09 2Tablet
10 2Blank
01 2Prescription
02 14RX
03 12Blank
01 8ASENAPINE MALEATE
02 5SAPHRIS
03 3SECUADO
04 2Saphris
05 8Sycrest
06 2Blank
01 2Australia
02 2Canada
03 2India
04 2Italy
05 2Norway
06 2Sweden
07 2Switzerland
08 14USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SAPHRIS
Dosage Form : TABLET;SUBLINGUAL
Dosage Strength : EQ 5MG BASE
Packaging :
Approval Date : 2009-08-13
Application Number : 22117
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ASENAPINE MALEATE
Dosage Form : TABLET;SUBLINGUAL
Dosage Strength : EQ 2.5MG BASE
Packaging :
Approval Date : 2020-12-10
Application Number : 205960
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SAPHRIS
Dosage Form : TABLET;SUBLINGUAL
Dosage Strength : EQ 10MG BASE
Packaging :
Approval Date : 2009-08-13
Application Number : 22117
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SAPHRIS
Dosage Form : TABLET;SUBLINGUAL
Dosage Strength : EQ 2.5MG BASE
Packaging :
Approval Date : 2015-03-12
Application Number : 22117
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ASENAPINE MALEATE
Dosage Form : TABLET;SUBLINGUAL
Dosage Strength : EQ 10MG BASE
Packaging :
Approval Date : 2020-12-10
Application Number : 205960
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ASENAPINE MALEATE
Dosage Form : TABLET;SUBLINGUAL
Dosage Strength : EQ 5MG BASE
Packaging :
Approval Date : 2021-03-08
Application Number : 205960
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ASENAPINE MALEATE
Dosage Form : TABLET;SUBLINGUAL
Dosage Strength : EQ 5MG BASE
Packaging :
Approval Date : 2020-12-10
Application Number : 206098
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ASENAPINE MALEATE
Dosage Form : TABLET;SUBLINGUAL
Dosage Strength : EQ 10MG BASE
Packaging :
Approval Date : 2020-12-10
Application Number : 206098
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ASENAPINE MALEATE
Dosage Form : TABLET;SUBLINGUAL
Dosage Strength : EQ 2.5MG BASE
Packaging :
Approval Date : 2021-07-19
Application Number : 206098
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SECUADO
Dosage Form : SYSTEM;TRANSDERMAL
Dosage Strength : 3.8MG/24HR
Packaging :
Approval Date : 2019-10-11
Application Number : 212268
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SECUADO
Dosage Form : SYSTEM;TRANSDERMAL
Dosage Strength : 5.7MG/24HR
Packaging :
Approval Date : 2019-10-11
Application Number : 212268
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SECUADO
Dosage Form : SYSTEM;TRANSDERMAL
Dosage Strength : 7.6MG/24HR
Packaging :
Approval Date : 2019-10-11
Application Number : 212268
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 10mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : Sweden
Brand Name : Sycrest
Dosage Form : SUBLINGUAL TABLET
Dosage Strength : 10 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Sycrest
Dosage Form : SUBLINGUAL TABLET
Dosage Strength : 5 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Sycrest
Dosage Form : Asenapina 10Mg 60 Units Sublingual Use
Dosage Strength : 60 sublingual cpr 10 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Sycrest
Dosage Form : Asenapina 5Mg 60 Units Sublingual Use
Dosage Strength : 60 sublingual CPR 5 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Switzerland
Brand Name : Sycrest
Dosage Form : Subling Tabl
Dosage Strength : 10mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Sycrest
Dosage Form : Subling Tabl
Dosage Strength : 5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Australia
Brand Name : Saphris
Dosage Form :
Dosage Strength :
Packaging : 60
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Saphris
Dosage Form :
Dosage Strength :
Packaging : 60
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : RX
Registration Country : USA
Brand Name : ASENAPINE MALEATE
Dosage Form : TABLET;SUBLINGUAL
Dosage Strength : EQ 5MG BASE
Packaging :
Approval Date : 2020-12-10
Application Number : 206107
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ASENAPINE MALEATE
Dosage Form : TABLET;SUBLINGUAL
Dosage Strength : EQ 10MG BASE
Packaging :
Approval Date : 2020-12-10
Application Number : 206107
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Norway
Brand Name : Sycrest
Dosage Form : Sublingvaltablett
Dosage Strength : 10 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Norway
Brand Name : Sycrest
Dosage Form : Sublingvaltablett
Dosage Strength : 5 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : SAPHRIS
Dosage Form : TABLET
Dosage Strength : 5MG
Packaging : 20/60
Approval Date :
Application Number : 2374803
Regulatory Info : Prescription
Registration Country : Canada
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : SAPHRIS
Dosage Form : TABLET
Dosage Strength : 10MG
Packaging : 20/60
Approval Date :
Application Number : 2374811
Regulatory Info : Prescription
Registration Country : Canada
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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