Application 202939
- Type
- ANDA
- Sponsor
- INTELLIPHARMACEUTICS
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 50MG BASE | No | No |
| 002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 150MG BASE | No | No |
| 003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 200MG BASE | No | No |
| 004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 300MG BASE | No | No |
| 005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 400MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0406-1180 | Quetiapine Fumarate | Quetiapine Fumarate | SpecGx LLC | ANDA | Current |
| 0406-1180 | Quetiapine Fumarate | Quetiapine Fumarate | SpecGx LLC | ANDA | Current |
| 0406-1181 | Quetiapine Fumarate | Quetiapine Fumarate | SpecGx LLC | ANDA | Current |
| 0406-1181 | Quetiapine Fumarate | Quetiapine Fumarate | SpecGx LLC | ANDA | Current |
| 0406-1182 | Quetiapine Fumarate | Quetiapine Fumarate | SpecGx LLC | ANDA | Current |
| 0406-1182 | Quetiapine Fumarate | Quetiapine Fumarate | SpecGx LLC | ANDA | Current |
| 0406-1183 | Quetiapine Fumarate | Quetiapine Fumarate | SpecGx LLC | ANDA | Current |
| 0406-1183 | Quetiapine Fumarate | Quetiapine Fumarate | SpecGx LLC | ANDA | Current |
| 0406-1184 | Quetiapine Fumarate | Quetiapine Fumarate | SpecGx LLC | ANDA | Current |
| 0406-1184 | Quetiapine Fumarate | Quetiapine Fumarate | SpecGx LLC | ANDA | Current |
| 27808-185 | Quetiapine Fumarate | Quetiapine Fumarate | Tris Pharma Inc. | ANDA | Current |
| 27808-186 | Quetiapine Fumarate | Quetiapine Fumarate | Tris Pharma Inc. | ANDA | Current |
| 27808-187 | Quetiapine Fumarate | Quetiapine Fumarate | Tris Pharma Inc. | ANDA | Current |
| 27808-188 | Quetiapine Fumarate | Quetiapine Fumarate | Tris Pharma Inc. | ANDA | Current |
| 27808-189 | Quetiapine Fumarate | Quetiapine Fumarate | Tris Pharma Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 48374 | ORIG | 2017-05-15 |
| 48365 | ORIG | 2017-05-12 |