Application 020778
- Type
- NDA
- Sponsor
- AGOURON PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VIRACEPT | NELFINAVIR MESYLATE | POWDER;ORAL | EQ 50MG BASE/SCOOPFUL | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 66878 | SUPPL | 2021-03-25 |
| 66872 | SUPPL | 2021-03-25 |
| 45360 | SUPPL | 2016-09-22 |
| 45304 | SUPPL | 2016-09-15 |
| 35327 | SUPPL | 2015-04-07 |
| 25785 | SUPPL | 2015-03-31 |
| 35326 | SUPPL | 2013-06-04 |
| 25784 | SUPPL | 2013-05-31 |
| 25782 | SUPPL | 2012-04-11 |
| 13405 | SUPPL | 2012-04-09 |
| 25783 | SUPPL | 2012-02-27 |
| 35325 | SUPPL | 2012-02-24 |
| 13404 | SUPPL | 2011-03-10 |
| 3325 | SUPPL | 2011-02-28 |
| 35324 | SUPPL | 2010-05-03 |
| 13403 | SUPPL | 2010-05-03 |
| 3324 | SUPPL | 2010-04-28 |
| 3323 | SUPPL | 2010-04-28 |
| 25781 | SUPPL | 2008-11-26 |
| 35323 | SUPPL | 2008-02-14 |
| 3322 | SUPPL | 2008-02-14 |
| 35322 | SUPPL | 2007-12-03 |
| 41689 | SUPPL | 2007-08-06 |
| 41688 | SUPPL | 2007-08-06 |
| 20935 | SUPPL | 2007-08-06 |
| 20934 | SUPPL | 2007-08-06 |
| 3321 | SUPPL | 2007-01-08 |
| 13402 | SUPPL | 2006-12-28 |
| 25780 | SUPPL | 2005-10-20 |
| 35321 | SUPPL | 2005-09-30 |
| 25779 | SUPPL | 2004-06-07 |
| 13401 | SUPPL | 2004-06-07 |
| 13400 | SUPPL | 2004-04-05 |
| 25778 | SUPPL | 2004-03-24 |
| 25777 | SUPPL | 2003-08-29 |
| 35320 | SUPPL | 2003-08-28 |
| 25776 | SUPPL | 2003-07-30 |
| 35319 | SUPPL | 2003-04-04 |
| 3320 | SUPPL | 2002-02-05 |
| 3319 | SUPPL | 2002-02-05 |
| 25775 | SUPPL | 2001-04-11 |
| 20933 | ORIG | 1997-03-14 |
| 52064 | ORIG | 1900-01-01 |
| 52063 | ORIG | 1900-01-01 |
| 52062 | ORIG | 1900-01-01 |
| 52061 | ORIG | 1900-01-01 |