Application 207655
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
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 |
|---|
| 50090-3595 | Quetiapine Fumarate | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 50090-5451 | Quetiapine Fumarate | Quetiapine | A-S Medication Solutions | ANDA | Current |
| 65862-873 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-873 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-873 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-873 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-873 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-873 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-873 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-873 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-874 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-874 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-874 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-874 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-874 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-874 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-874 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-874 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-875 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-875 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-875 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-875 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-875 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-875 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-875 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-875 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-876 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-876 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-876 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-876 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-876 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-876 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-876 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-876 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-877 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-877 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-877 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-877 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-877 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-877 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-877 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-877 | Quetiapine Fumarate | Quetiapine | Aurobindo Pharma Limited | ANDA | Current |