SAPHRIS is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Asenapine Maleate.
Product ID | 0456-2405_3f3771cc-64e2-43e7-ac4c-b41d51c77ca9 |
NDC | 0456-2405 |
Product Type | Human Prescription Drug |
Proprietary Name | SAPHRIS |
Generic Name | Asenapine Maleate |
Dosage Form | Tablet |
Route of Administration | SUBLINGUAL |
Marketing Start Date | 2013-09-30 |
Marketing Category | NDA / NDA |
Application Number | NDA022117 |
Labeler Name | Allergan, Inc. |
Substance Name | ASENAPINE MALEATE |
Active Ingredient Strength | 5 mg/1 |
Pharm Classes | Atypical Antipsychotic [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2013-09-30 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA022117 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2013-09-30 |
Marketing Category | NDA |
Application Number | NDA022117 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2013-09-30 |
Marketing Category | NDA |
Application Number | NDA022117 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2013-09-30 |
Marketing Category | NDA |
Application Number | NDA022117 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2013-09-30 |
Marketing Category | NDA |
Application Number | NDA022117 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2013-09-30 |
Marketing End Date | 2014-12-05 |
Marketing Category | NDA |
Application Number | NDA022117 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2015-12-11 |
Ingredient | Strength |
---|---|
ASENAPINE MALEATE | 5 mg/1 |
SPL SET ID: | 5429f134-839f-4ffc-9944-55f51238def8 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
NDC | Brand Name | Generic Name |
---|---|---|
0052-0118 | SAPHRIS | Asenapine Maleate |
0052-0119 | SAPHRIS | Asenapine Maleate |
0052-2139 | SAPHRIS | Asenapine Maleate |
0052-2142 | SAPHRIS | Asenapine Maleate |
0456-2402 | SAPHRIS | Asenapine Maleate |
0456-2405 | SAPHRIS | Asenapine Maleate |
0456-2410 | SAPHRIS | Asenapine Maleate |
51991-358 | Asenapine | ASENAPINE MALEATE |
51991-359 | Asenapine | ASENAPINE MALEATE |
51991-360 | Asenapine | ASENAPINE MALEATE |
51991-361 | Asenapine | ASENAPINE MALEATE |
51991-928 | Asenapine | ASENAPINE MALEATE |
59762-1091 | Asenapine | asenapine maleate |
59762-2012 | Asenapine | asenapine maleate |
59762-2888 | Asenapine | asenapine maleate |
69539-057 | Asenapine | ASENAPINE MALEATE |
69539-058 | Asenapine | ASENAPINE MALEATE |
69539-059 | Asenapine | ASENAPINE MALEATE |
69539-060 | Asenapine | ASENAPINE MALEATE |
69539-245 | Asenapine | ASENAPINE MALEATE |
64330-625 | Asenapine Maleate | Asenapine Maleate |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SAPHRIS 79411096 not registered Live/Pending |
N.V. Organon 2024-11-07 |
SAPHRIS 79002251 2942245 Live/Registered |
MERCK SHARP & DOHME B.V. 2004-04-05 |
SAPHRIS 77666398 3865200 Live/Registered |
MERCK SHARP & DOHME B.V. 2009-02-09 |