Application 021246
- Type
- NDA
- Sponsor
- ROCHE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TAMIFLU | OSELTAMIVIR PHOSPHATE | FOR SUSPENSION;ORAL | EQ 12MG BASE/ML | No | No |
| 002 | TAMIFLU | OSELTAMIVIR PHOSPHATE | FOR SUSPENSION;ORAL | EQ 6MG BASE/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0004-0822 | Tamiflu | Oseltamivir Phosphate | Genentech, Inc. | NDA | Current |
| 0004-0822 | Tamiflu | Oseltamivir Phosphate | Genentech, Inc. | NDA | Current |
| 0004-0822 | Tamiflu | Oseltamivir Phosphate | Genentech, Inc. | NDA | Current |
| 0004-0822 | Tamiflu | Oseltamivir Phosphate | Genentech, Inc. | NDA | Current |
| 0004-0822 | Tamiflu | Oseltamivir Phosphate | Genentech, Inc. | NDA | Current |
| 42254-092 | Tamiflu | Oseltamivir Phosphate | Rebel Distributors Corp | NDA | Current |
| 50090-1244 | Tamiflu | Oseltamivir Phosphate | A-S Medication Solutions | NDA | Current |
| 50090-1244 | Tamiflu | Oseltamivir Phosphate | A-S Medication Solutions | NDA | Current |
| 55045-3198 | Tamiflu | oseltamivir phosphate | Dispensing Solutions, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 68337 | SUPPL | 2021-08-11 |
| 59577 | SUPPL | 2019-08-05 |
| 59571 | SUPPL | 2019-08-05 |
| 56807 | SUPPL | 2018-12-19 |
| 56797 | SUPPL | 2018-12-19 |
| 53668 | SUPPL | 2018-04-13 |
| 53630 | SUPPL | 2018-04-06 |
| 4754 | SUPPL | 2016-06-22 |
| 36447 | SUPPL | 2016-06-21 |
| 42050 | SUPPL | 2015-07-22 |
| 21542 | SUPPL | 2015-07-20 |
| 36443 | SUPPL | 2014-12-03 |
| 27190 | SUPPL | 2014-11-28 |
| 27192 | SUPPL | 2014-10-16 |
| 14724 | SUPPL | 2014-10-15 |
| 21540 | SUPPL | 2014-07-07 |
| 36446 | SUPPL | 2014-06-03 |
| 4753 | SUPPL | 2014-06-03 |
| 44475 | SUPPL | 2013-08-12 |
| 36444 | SUPPL | 2013-08-12 |
| 21543 | SUPPL | 2013-06-03 |
| 21541 | SUPPL | 2013-06-03 |
| 21544 | SUPPL | 2013-04-08 |
| 4752 | SUPPL | 2013-01-29 |
| 36445 | SUPPL | 2012-12-21 |
| 27191 | SUPPL | 2012-12-21 |
| 24189 | SUPPL | 2012-12-21 |
| 4751 | SUPPL | 2012-08-20 |
| 14723 | SUPPL | 2012-08-17 |
| 4750 | SUPPL | 2011-03-24 |
| 36441 | SUPPL | 2011-03-23 |
| 27189 | SUPPL | 2011-02-09 |
| 36442 | SUPPL | 2011-02-07 |
| 4746 | SUPPL | 2010-12-21 |
| 14720 | SUPPL | 2010-12-16 |
| 4749 | SUPPL | 2010-11-10 |
| 36440 | SUPPL | 2010-11-05 |
| 36439 | SUPPL | 2010-03-03 |
| 14722 | SUPPL | 2010-03-03 |
| 27188 | SUPPL | 2010-02-26 |
| 27187 | SUPPL | 2010-02-26 |
| 27183 | SUPPL | 2009-10-21 |
| 4745 | SUPPL | 2009-10-21 |
| 4744 | SUPPL | 2009-10-21 |
| 4742 | SUPPL | 2009-10-21 |
| 27181 | SUPPL | 2009-10-19 |
| 27179 | SUPPL | 2009-10-19 |
| 27178 | SUPPL | 2009-10-19 |
| 4747 | SUPPL | 2009-10-19 |
| 4743 | SUPPL | 2009-10-19 |
| 4741 | SUPPL | 2009-10-19 |
| 4740 | SUPPL | 2009-10-19 |
| 4739 | SUPPL | 2009-10-19 |
| 4738 | SUPPL | 2009-10-19 |
| 4737 | SUPPL | 2009-10-19 |
| 4736 | SUPPL | 2009-10-16 |
| 14721 | SUPPL | 2009-04-30 |
| 4748 | SUPPL | 2009-04-30 |
| 36438 | SUPPL | 2008-01-18 |
| 27186 | SUPPL | 2008-01-18 |
| 27185 | SUPPL | 2007-10-10 |
| 14719 | SUPPL | 2007-10-10 |
| 27184 | SUPPL | 2007-07-05 |
| 14718 | SUPPL | 2007-07-05 |
| 42049 | SUPPL | 2007-06-22 |
| 42048 | SUPPL | 2007-06-22 |
| 42047 | SUPPL | 2007-06-22 |
| 21539 | SUPPL | 2007-06-22 |
| 21538 | SUPPL | 2007-06-22 |
| 21537 | SUPPL | 2007-06-22 |
| 21536 | SUPPL | 2007-06-22 |
| 27182 | SUPPL | 2006-11-16 |
| 36437 | SUPPL | 2006-11-14 |
| 23069 | SUPPL | 2006-11-14 |
| 27180 | SUPPL | 2006-01-18 |
| 23068 | SUPPL | 2006-01-10 |
| 36436 | SUPPL | 2006-01-05 |
| 21535 | ORIG | 2004-08-09 |
| 36435 | SUPPL | 2004-07-01 |
| 27177 | SUPPL | 2004-07-01 |
| 44108 | ORIG | 2003-12-12 |
| 14716 | SUPPL | 2003-05-01 |
| 14715 | SUPPL | 2003-05-01 |
| 14717 | SUPPL | 2003-04-22 |
| 36434 | SUPPL | 2002-04-26 |
| 4735 | SUPPL | 2002-04-26 |
| 14714 | ORIG | 2000-12-14 |
| 4734 | ORIG | 2000-12-14 |