Skip to content
Application 206954
- Type
- ANDA
- Sponsor
- PRINSTON INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 25MG BASE | No | No |
| 002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 50MG BASE | No | No |
| 003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 100MG BASE | No | No |
| 004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 200MG BASE | No | No |
| 005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 300MG BASE | No | No |
| 006 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 400MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 43547-518 | QUETIAPINE | quetiapine | Solco Healthcare US, LLC | ANDA | Current |
| 43547-519 | QUETIAPINE | quetiapine | Solco Healthcare US, LLC | ANDA | Current |
| 43547-520 | QUETIAPINE | quetiapine | Solco Healthcare US, LLC | ANDA | Current |
| 43547-521 | QUETIAPINE | quetiapine | Solco Healthcare US, LLC | ANDA | Current |
| 43547-522 | QUETIAPINE | quetiapine | Solco Healthcare US, LLC | ANDA | Current |
| 43547-523 | QUETIAPINE | quetiapine | Solco Healthcare US, LLC | ANDA | Current |