Application 020151
- Type
- NDA
- Sponsor
- WYETH PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | TABLET;ORAL | EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | TABLET;ORAL | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | TABLET;ORAL | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | TABLET;ORAL | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | TABLET;ORAL | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 006 | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | TABLET;ORAL | EQ 37.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 46125 | SUPPL | 2016-12-09 |
| 2086 | SUPPL | 2012-12-19 |
| 2084 | SUPPL | 2012-12-19 |
| 2082 | SUPPL | 2012-12-19 |
| 2071 | SUPPL | 2012-12-19 |
| 34312 | SUPPL | 2012-12-13 |
| 34301 | SUPPL | 2012-12-13 |
| 12258 | SUPPL | 2012-12-13 |
| 12256 | SUPPL | 2012-12-13 |
| 2085 | SUPPL | 2012-05-09 |
| 12259 | SUPPL | 2012-05-07 |
| 2080 | SUPPL | 2010-01-19 |
| 21218 | SUPPL | 2010-01-14 |
| 2083 | SUPPL | 2010-01-14 |
| 34311 | SUPPL | 2010-01-08 |
| 12257 | SUPPL | 2010-01-08 |
| 34310 | SUPPL | 2009-11-13 |
| 12255 | SUPPL | 2009-02-04 |
| 2081 | SUPPL | 2009-02-03 |
| 34308 | SUPPL | 2008-11-20 |
| 21216 | SUPPL | 2008-05-28 |
| 34309 | SUPPL | 2008-02-14 |
| 21217 | SUPPL | 2008-02-14 |
| 2075 | SUPPL | 2008-02-05 |
| 20486 | SUPPL | 2007-11-19 |
| 20485 | SUPPL | 2007-11-19 |
| 20484 | SUPPL | 2007-11-19 |
| 34307 | SUPPL | 2007-09-26 |
| 34306 | SUPPL | 2007-09-26 |
| 2079 | SUPPL | 2007-09-25 |
| 2078 | SUPPL | 2007-09-25 |
| 34305 | SUPPL | 2007-08-02 |
| 21215 | SUPPL | 2007-08-02 |
| 12254 | SUPPL | 2007-08-02 |
| 41158 | SUPPL | 2007-07-06 |
| 20480 | SUPPL | 2007-07-06 |
| 41161 | SUPPL | 2007-07-05 |
| 41160 | SUPPL | 2007-07-05 |
| 41159 | SUPPL | 2007-07-05 |
| 41157 | SUPPL | 2007-07-05 |
| 20483 | SUPPL | 2007-07-05 |
| 20482 | SUPPL | 2007-07-05 |
| 20481 | SUPPL | 2007-07-05 |
| 34302 | SUPPL | 2007-02-21 |
| 2076 | SUPPL | 2007-02-12 |
| 34304 | SUPPL | 2006-10-23 |
| 2077 | SUPPL | 2006-10-23 |
| 21214 | SUPPL | 2006-09-20 |
| 34303 | SUPPL | 2006-09-15 |
| 2073 | SUPPL | 2006-03-01 |
| 21213 | SUPPL | 2006-01-20 |
| 2074 | SUPPL | 2006-01-20 |
| 23569 | ORIG | 2005-04-15 |
| 21212 | SUPPL | 2005-02-23 |
| 34299 | SUPPL | 2004-06-02 |
| 34300 | SUPPL | 2004-05-27 |
| 12253 | SUPPL | 2004-05-27 |
| 12252 | SUPPL | 2004-05-27 |
| 21211 | SUPPL | 2004-05-26 |
| 2072 | SUPPL | 2004-05-26 |
| 2070 | SUPPL | 2004-05-26 |
| 2068 | SUPPL | 2004-05-07 |
| 2069 | SUPPL | 2004-04-20 |
| 21210 | SUPPL | 2004-03-24 |
| 2067 | SUPPL | 2003-07-30 |
| 2066 | SUPPL | 2003-07-30 |
| 12251 | SUPPL | 2003-04-24 |
| 53536 | SUPPL | 1900-01-01 |
| 53535 | SUPPL | 1900-01-01 |
| 52225 | SUPPL | 1900-01-01 |
| 52223 | SUPPL | 1900-01-01 |
| 52222 | SUPPL | 1900-01-01 |