Application 209497
- Type
- ANDA
- Sponsor
- ALIGNSCIENCE PHARMA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | No | No |
| 002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 200MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69948-002 | Quetiapine | Quetiapine | AlignScience Pharma Inc. | ANDA | Current |
| 69948-002 | Quetiapine | Quetiapine | AlignScience Pharma Inc. | ANDA | Current |
| 69948-003 | Quetiapine | Quetiapine | AlignScience Pharma Inc. | ANDA | Current |
| 69948-003 | Quetiapine | Quetiapine | AlignScience Pharma Inc. | ANDA | Current |