Application 019462
- Type
- NDA
- Sponsor
- VALEANT PHARMS NORTH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PEPCID | FAMOTIDINE | TABLET;ORAL | 20MG | Yes | No |
| 002 | PEPCID | FAMOTIDINE | TABLET;ORAL | 40MG | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 56427 | SUPPL | 2018-11-23 |
| 56447 | SUPPL | 2018-11-15 |
| 54697 | SUPPL | 2018-06-27 |
| 54662 | SUPPL | 2018-06-21 |
| 17411 | SUPPL | 2014-02-10 |
| 33754 | SUPPL | 2014-02-06 |
| 33753 | SUPPL | 2011-06-07 |
| 1333 | SUPPL | 2011-06-03 |
| 33752 | SUPPL | 2010-03-26 |
| 1332 | SUPPL | 2010-03-25 |
| 17410 | SUPPL | 2007-11-08 |
| 11510 | SUPPL | 2007-11-07 |
| 20246 | SUPPL | 2007-07-09 |
| 11508 | ORIG | 2003-04-30 |
| 33751 | SUPPL | 2003-04-24 |
| 17409 | SUPPL | 2002-06-06 |
| 11509 | SUPPL | 2002-06-06 |
| 1331 | SUPPL | 2001-03-14 |
| 20245 | SUPPL | 1999-03-18 |
| 57456 | ORIG | 1986-10-15 |