Application 091388
- 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;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 150MG BASE | No | No |
| 005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 200MG BASE | No | No |
| 006 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET;ORAL | EQ 300MG BASE | No | No |
| 007 | 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 |
|---|
| 16571-717 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-717 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-717 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-718 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-718 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-718 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-719 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-719 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-719 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-720 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-720 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-720 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-721 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-721 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-721 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-722 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-722 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-722 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-809 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-809 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-809 | Quetiapine Fumarate | Quetiapine Fumarate | Rising Pharma Holdings, Inc. | ANDA | Current |
| 48433-324 | Quetiapine Fumarate | Quetiapine Fumarate | Safecor Health, LLC | ANDA | Current |
| 57237-079 | Quetiapine Fumarate | Quetiapine Fumarate | Citron Pharma LLC | ANDA | Current |
| 57237-080 | Quetiapine Fumarate | Quetiapine Fumarate | Citron Pharma LLC | ANDA | Current |
| 57237-081 | Quetiapine Fumarate | Quetiapine Fumarate | Citron Pharma LLC | ANDA | Current |
| 57237-082 | Quetiapine Fumarate | Quetiapine Fumarate | Citron Pharma LLC | ANDA | Current |
| 57237-083 | Quetiapine Fumarate | Quetiapine Fumarate | Citron Pharma LLC | ANDA | Current |
| 57237-084 | Quetiapine Fumarate | Quetiapine Fumarate | Citron Pharma LLC | ANDA | Current |
| 65862-489 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-489 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-489 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-489 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-489 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-489 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-489 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-490 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-490 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-490 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-490 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-490 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-490 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-490 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-491 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-491 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-491 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-491 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-491 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-491 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-491 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-492 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-492 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-492 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-492 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-492 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-492 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-492 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-493 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-493 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-493 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-493 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-493 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-493 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-493 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-494 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-494 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-494 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-494 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-494 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-494 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-494 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-495 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-495 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-495 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-495 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-495 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-495 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-495 | Quetiapine Fumarate | Quetiapine Fumarate | Aurobindo Pharma Limited | ANDA | Current |
| 70518-3429 | Quetiapine Fumarate | Quetiapine Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3581 | Quetiapine Fumarate | Quetiapine Fumarate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3609 | Quetiapine Fumarate | Quetiapine Fumarate | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9336 | ORIG | 2012-03-30 |