Application 020885
- Type
- NDA
- Sponsor
- APOTEX TECHNOLOGIES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PAXIL | PAROXETINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | PAXIL | PAROXETINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | PAXIL | PAROXETINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | PAXIL | PAROXETINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 41783 | SUPPL | 2011-12-09 |
| 41782 | SUPPL | 2011-12-09 |
| 21042 | SUPPL | 2011-12-09 |
| 23607 | ORIG | 2005-08-01 |
| 21041 | ORIG | 1998-10-09 |
| 3654 | ORIG | 1998-10-09 |