Application 011000
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COMPAZINE | PROCHLORPERAZINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 10MG BASE | No | No |
| 002 | COMPAZINE | PROCHLORPERAZINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 15MG BASE | No | No |
| 003 | COMPAZINE | PROCHLORPERAZINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 30MG BASE | No | No |
| 004 | COMPAZINE | PROCHLORPERAZINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 75MG BASE | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 11918 | SUPPL | 2001-04-03 |