Paroxetine Oral Capsule
- Brand(s)
- Brisdelle
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Noven Therapeutics, Llc (2014-12-04)
- Oldest Current Product
- 2013-06-28
- License(s)
- NDA
- RxNORM
- ORAL CAPSULE\PAROXETINE
- FDAOB
- ORAL\CAPSULE\PAROXETINE MESYLATE
- SPL Active
- ORAL\CAPSULE\PAROXETINE MESYLATE
- SPL Moiety
- ORAL\CAPSULE\PAROXETINE
product(s) by strength(s)
paroxetine 7.5 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 689689075 | Brisdelle | NDA | Noven Therapeutics, Llc | 2013-06-28 | PAROXETINE MESYLATE | ORAL | CAPSULE | NDA204516 | bf208751-e6d8-11e1-aff1-0800200c9a66 |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA204516 | BRISDELLE | NOVEN THERAPEUTICS LLC | 2013-06-28 | p8658663, TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE, SUBSTANCE p8946251, TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE, SUBSTANCE p5874447 p7598271 | NEW PRODUCT [2016-06-28] | NDA204516_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA204516_001 | RX | PAROXETINE MESYLATE (EQ 7.5MG BASE) | ORAL | CAPSULE | True | 2013-06-28 | BRISDELLE |
patent(s)
| # | id | expiration date | application(s) | in other drug docs |
|---|---|---|---|---|
| 1 | p5874447 (view patent) | 2017-06-10 | NDA204516, NDA021299 | Paroxetine Oral Tablet |
| 2 | p7598271 (view patent) | 2023-02-12 | NDA204516, NDA021299 | Paroxetine Oral Tablet |
| 3 | p8658663 (view patent) | 2029-04-06 | NDA204516 | |
| 4 | p8946251 (view patent) | 2026-08-04 | NDA204516 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | bf208751-e6d8-11e1-aff1-0800200c9a66 (view SPL) | These highlights do not include all the information needed to use BRISDELLE safely and effectively. See full prescribing information for BRISDELLE. BRISDELLE (paroxetine) capsules, for oral use Initial U.S. Approval: 1992 | prescription | Human Prescription | Noven Therapeutics, Llc | ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK | 2014-12-04 | 6 | 689689075 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII