Application 021763
- Type
- NDA
- Sponsor
- BIOVAIL LABS INTL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 10MG BASE | No | No |
| 002 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 20MG BASE | No | No |
| 003 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 40MG BASE | No | No |
| 004 | CITALOPRAM HYDROBROMIDE | CITALOPRAM HYDROBROMIDE | TABLET; ORALLY DISINTEGRATING | 40MG | No | No |