PEXEVA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sebela Pharmaceuticals Inc.. The primary component is Paroxetine Mesylate.
Product ID | 54766-204_7d24951f-636d-74ed-e053-2a91aa0aa29a |
NDC | 54766-204 |
Product Type | Human Prescription Drug |
Proprietary Name | PEXEVA |
Generic Name | Paroxetine Mesylate |
Dosage Form | Tablet, Film Coated |
Route of Administration | ORAL |
Marketing Start Date | 2017-06-02 |
Marketing Category | NDA / NDA |
Application Number | NDA021299 |
Labeler Name | Sebela Pharmaceuticals Inc. |
Substance Name | PAROXETINE MESYLATE |
Active Ingredient Strength | 40 mg/1 |
Pharm Classes | Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2017-06-02 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA021299 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2017-06-02 |
Ingredient | Strength |
---|---|
PAROXETINE MESYLATE | 40 mg/1 |
SPL SET ID: | 50fe88bd-f0dd-5fad-e054-00144ff8d46c |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI | |
UPC Code |
NDC | Brand Name | Generic Name |
---|---|---|
54766-201 | PEXEVA | paroxetine mesylate |
54766-202 | PEXEVA | paroxetine mesylate |
54766-203 | PEXEVA | paroxetine mesylate |
54766-204 | PEXEVA | paroxetine mesylate |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PEXEVA 78271367 2899689 Live/Registered |
SEBELA IRELAND LIMITED 2003-07-08 |
![]() PEXEVA 76615948 3033803 Live/Registered |
SEBELA IRELAND LIMITED 2004-10-14 |