Application 209635
- Type
- ANDA
- Sponsor
- SCIEGEN PHARMS INC
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 |
| 003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 300MG BASE | No | No |
| 004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 400MG BASE | No | No |
| 005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 50MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10135-656 | Quetiapine | Quetiapine | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-656 | Quetiapine | Quetiapine | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-657 | Quetiapine | Quetiapine | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-657 | Quetiapine | Quetiapine | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-658 | Quetiapine | Quetiapine | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-658 | Quetiapine | Quetiapine | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-659 | Quetiapine | Quetiapine | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-659 | Quetiapine | Quetiapine | Marlex Pharmaceuticals Inc | ANDA | Current |
| 50228-380 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-380 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-380 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-380 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-380 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-381 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-381 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-381 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-381 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-381 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-382 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-382 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-382 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-382 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-382 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-383 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-383 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-383 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-383 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-383 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-384 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-384 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-384 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-384 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 50228-384 | Quetiapine | Quetiapine | ScieGen Pharmaceuticals, Inc | ANDA | Current |
| 63629-2478 | Quetiapine | Quetiapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2478 | Quetiapine | Quetiapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2479 | Quetiapine | Quetiapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2479 | Quetiapine | Quetiapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2480 | Quetiapine | Quetiapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2480 | Quetiapine | Quetiapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2481 | Quetiapine | Quetiapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2481 | Quetiapine | Quetiapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2482 | Quetiapine | Quetiapine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2482 | Quetiapine | Quetiapine | Bryant Ranch Prepack | ANDA | Current |
| 70518-1744 | Quetiapine | Quetiapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1744 | Quetiapine | Quetiapine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1823 | Quetiapine | Quetiapine | REMEDYREPACK INC. | ANDA | Current |
| 71093-135 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-135 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-135 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-135 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-135 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-136 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-136 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-136 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-136 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-136 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-137 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-137 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-137 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-137 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-137 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-138 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-138 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-138 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-138 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-138 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-139 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-139 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-139 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-139 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-139 | Quetiapine | Quetiapine | ACI Healthcare USA, Inc. | ANDA | Current |
| 71399-1500 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | Akron Pharma Inc | ANDA | Current |
| 71399-2000 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | Akron Pharma Inc | ANDA | Current |
| 71399-3000 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | Akron Pharma Inc | ANDA | Current |
| 71399-4000 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | Akron Pharma Inc | ANDA | Current |