Application 020903
- Type
- NDA
- Sponsor
- MERCK SHARP DOHME
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | REBETOL | RIBAVIRIN | CAPSULE;ORAL | 200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy** | No | No |
| 002 | REBETOL | RIBAVIRIN | CAPSULE;ORAL | 200MG | Yes | Yes |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 70569 | SUPPL | 2022-03-21 |
| 70568 | SUPPL | 2022-03-21 |
| 70541 | SUPPL | 2022-03-17 |
| 68747 | SUPPL | 2021-09-24 |
| 61725 | SUPPL | 2020-01-29 |
| 61724 | SUPPL | 2020-01-29 |
| 61716 | SUPPL | 2020-01-29 |
| 58555 | SUPPL | 2019-05-03 |
| 58547 | SUPPL | 2019-05-03 |
| 35616 | SUPPL | 2015-05-27 |
| 26161 | SUPPL | 2015-05-22 |
| 13717 | SUPPL | 2013-11-22 |
| 3713 | SUPPL | 2013-11-18 |
| 35615 | SUPPL | 2013-06-04 |
| 26160 | SUPPL | 2013-06-04 |
| 35614 | SUPPL | 2013-02-08 |
| 3712 | SUPPL | 2013-02-08 |
| 26159 | SUPPL | 2011-05-10 |
| 26158 | SUPPL | 2010-11-03 |
| 13716 | SUPPL | 2010-10-29 |
| 26157 | SUPPL | 2010-01-20 |
| 3711 | SUPPL | 2010-01-20 |
| 3710 | SUPPL | 2010-01-20 |
| 3709 | SUPPL | 2010-01-20 |
| 35613 | SUPPL | 2009-11-16 |
| 35612 | SUPPL | 2009-11-16 |
| 13715 | SUPPL | 2009-11-16 |
| 13714 | SUPPL | 2009-11-16 |
| 21267 | SUPPL | 2008-08-01 |
| 21266 | SUPPL | 2008-08-01 |
| 26156 | SUPPL | 2008-01-09 |
| 13713 | SUPPL | 2007-12-14 |
| 13712 | SUPPL | 2007-04-20 |
| 3708 | SUPPL | 2007-04-20 |
| 26155 | SUPPL | 2006-09-18 |
| 35611 | SUPPL | 2006-08-29 |
| 41797 | SUPPL | 2005-04-15 |
| 41796 | SUPPL | 2005-04-15 |
| 41795 | SUPPL | 2005-04-15 |
| 21265 | SUPPL | 2005-04-15 |
| 21053 | SUPPL | 2005-04-15 |
| 13711 | SUPPL | 2004-06-24 |
| 3707 | SUPPL | 2004-06-24 |
| 3706 | SUPPL | 2004-06-14 |
| 26154 | SUPPL | 2004-06-10 |
| 13710 | SUPPL | 2004-06-10 |
| 41794 | SUPPL | 2004-06-04 |
| 21052 | SUPPL | 2004-06-04 |
| 26153 | SUPPL | 2003-10-16 |
| 13709 | SUPPL | 2003-10-16 |
| 41793 | ORIG | 2003-08-08 |
| 26151 | SUPPL | 2003-07-31 |
| 35610 | SUPPL | 2003-07-09 |
| 35609 | SUPPL | 2003-06-22 |
| 3705 | SUPPL | 2003-06-22 |
| 26152 | SUPPL | 2003-06-08 |
| 13708 | SUPPL | 2003-06-08 |
| 13706 | SUPPL | 2003-04-25 |
| 13705 | SUPPL | 2003-04-25 |
| 13703 | SUPPL | 2003-04-25 |
| 13702 | SUPPL | 2003-04-25 |
| 35608 | SUPPL | 2002-11-13 |
| 13707 | SUPPL | 2002-09-03 |
| 3704 | SUPPL | 2002-09-03 |
| 26150 | SUPPL | 2002-03-06 |
| 26149 | SUPPL | 2002-02-21 |
| 3702 | SUPPL | 2001-12-28 |
| 35607 | SUPPL | 2001-07-26 |
| 35606 | SUPPL | 2001-07-26 |
| 35605 | SUPPL | 2001-07-26 |
| 26148 | SUPPL | 2001-07-26 |
| 13704 | SUPPL | 2001-07-26 |
| 3703 | SUPPL | 2001-07-26 |
| 3701 | SUPPL | 2001-07-26 |
| 3700 | SUPPL | 2001-07-26 |
| 3699 | SUPPL | 2001-03-13 |
| 3698 | SUPPL | 2001-03-13 |
| 35604 | SUPPL | 1998-12-09 |
| 26147 | SUPPL | 1998-12-09 |
| 13701 | SUPPL | 1998-12-09 |
| 3697 | SUPPL | 1998-12-09 |
| 35603 | ORIG | 1998-06-03 |
| 3696 | ORIG | 1998-06-03 |