Application 020710
- Type
- NDA
- Sponsor
- APOTEX TECHNOLOGIES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PAXIL | PAROXETINE HYDROCHLORIDE | SUSPENSION;ORAL | EQ 10MG BASE/5ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60505-0402 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-0402 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-0402 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-0402 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-0402 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-0402 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
| 60505-0402 | PAXIL | paroxetine hydrochloride | Apotex Corp | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80480 | SUPPL | 2024-12-03 |
| 80459 | SUPPL | 2024-12-02 |
| 80458 | SUPPL | 2024-12-02 |
| 68844 | SUPPL | 2021-10-01 |
| 68843 | SUPPL | 2021-10-01 |
| 68727 | SUPPL | 2021-09-23 |
| 66804 | SUPPL | 2021-03-18 |
| 66803 | SUPPL | 2021-03-18 |
| 66135 | SUPPL | 2021-02-09 |
| 46814 | SUPPL | 2017-01-13 |
| 46813 | SUPPL | 2017-01-13 |
| 46695 | SUPPL | 2017-01-06 |
| 13262 | SUPPL | 2014-07-29 |
| 25596 | SUPPL | 2014-07-23 |
| 13260 | SUPPL | 2012-12-31 |
| 3161 | SUPPL | 2012-12-21 |
| 35194 | SUPPL | 2012-04-17 |
| 3162 | SUPPL | 2012-04-12 |
| 41603 | SUPPL | 2011-12-09 |
| 41602 | SUPPL | 2011-12-09 |
| 41601 | SUPPL | 2011-12-09 |
| 13259 | SUPPL | 2011-07-12 |
| 13258 | SUPPL | 2011-07-12 |
| 3160 | SUPPL | 2011-07-12 |
| 3156 | SUPPL | 2011-07-12 |
| 35193 | SUPPL | 2011-03-28 |
| 35191 | SUPPL | 2011-03-28 |
| 13261 | SUPPL | 2011-03-28 |
| 25595 | SUPPL | 2011-03-24 |
| 3159 | SUPPL | 2011-03-24 |
| 3158 | SUPPL | 2011-03-24 |
| 25594 | SUPPL | 2010-11-02 |
| 35192 | SUPPL | 2010-10-28 |
| 25592 | SUPPL | 2009-11-19 |
| 35188 | SUPPL | 2009-11-05 |
| 35190 | SUPPL | 2009-02-04 |
| 25593 | SUPPL | 2009-02-03 |
| 35189 | SUPPL | 2008-11-07 |
| 3157 | SUPPL | 2008-11-03 |
| 41600 | SUPPL | 2007-09-24 |
| 41599 | SUPPL | 2007-09-24 |
| 20867 | SUPPL | 2007-09-24 |
| 25590 | SUPPL | 2007-08-07 |
| 35187 | SUPPL | 2007-08-03 |
| 25591 | SUPPL | 2006-09-20 |
| 3155 | SUPPL | 2006-09-20 |
| 25589 | SUPPL | 2006-02-08 |
| 3154 | SUPPL | 2006-02-08 |
| 44067 | ORIG | 2005-08-01 |