Application 021224
- Type
- NDA
- Sponsor
- JANSSEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RAZADYNE | GALANTAMINE HYDROBROMIDE | SOLUTION;ORAL | 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 47241 | SUPPL | 2017-02-16 |
| 47238 | SUPPL | 2017-02-16 |
| 27112 | SUPPL | 2015-12-17 |
| 14665 | SUPPL | 2015-12-17 |
| 4676 | SUPPL | 2015-02-12 |
| 36385 | SUPPL | 2015-02-10 |
| 14664 | SUPPL | 2013-07-11 |
| 4674 | SUPPL | 2013-07-02 |
| 36384 | SUPPL | 2012-05-01 |
| 36383 | SUPPL | 2012-03-06 |
| 14663 | SUPPL | 2012-03-06 |
| 27111 | SUPPL | 2012-03-05 |
| 4675 | SUPPL | 2012-03-05 |
| 4673 | SUPPL | 2012-03-05 |
| 27110 | SUPPL | 2006-05-01 |
| 27109 | SUPPL | 2006-05-01 |
| 4672 | SUPPL | 2006-05-01 |
| 4671 | SUPPL | 2006-05-01 |
| 23635 | ORIG | 2005-07-29 |
| 4670 | SUPPL | 2005-05-03 |
| 4669 | SUPPL | 2003-09-09 |
| 4668 | SUPPL | 2002-05-02 |
| 21518 | ORIG | 2002-03-05 |
| 14662 | ORIG | 2001-06-22 |
| 4667 | ORIG | 2001-06-22 |