Application 206251
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARIPIPRAZOLE | ARIPIPRAZOLE | TABLET;ORAL | 2MG | No | No |
| 002 | ARIPIPRAZOLE | ARIPIPRAZOLE | TABLET;ORAL | 5MG | No | No |
| 003 | ARIPIPRAZOLE | ARIPIPRAZOLE | TABLET;ORAL | 10MG | No | No |
| 004 | ARIPIPRAZOLE | ARIPIPRAZOLE | TABLET;ORAL | 15MG | No | No |
| 005 | ARIPIPRAZOLE | ARIPIPRAZOLE | TABLET;ORAL | 20MG | No | No |
| 006 | ARIPIPRAZOLE | ARIPIPRAZOLE | TABLET;ORAL | 30MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16729-278 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-278 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-278 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-278 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-278 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-279 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-279 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-279 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-279 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-279 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-280 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-280 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-280 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-280 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-280 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-281 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-281 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-281 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-281 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-281 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-282 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-282 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-282 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-282 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-282 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-283 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-283 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-283 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-283 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 16729-283 | ARIPIPRAZOLE | ARIPIPRAZOLE | Accord Healthcare, Inc. | ANDA | Current |
| 50090-3070 | ARIPIPRAZOLE | ARIPIPRAZOLE | A-S Medication Solutions | ANDA | Current |
| 50090-3073 | ARIPIPRAZOLE | ARIPIPRAZOLE | A-S Medication Solutions | ANDA | Current |
| 50090-3073 | ARIPIPRAZOLE | ARIPIPRAZOLE | A-S Medication Solutions | ANDA | Current |
| 50090-3941 | ARIPIPRAZOLE | ARIPIPRAZOLE | A-S Medication Solutions | ANDA | Current |
| 50090-3941 | ARIPIPRAZOLE | ARIPIPRAZOLE | A-S Medication Solutions | ANDA | Current |
| 50090-4160 | ARIPIPRAZOLE | ARIPIPRAZOLE | A-S Medication Solutions | ANDA | Current |
| 50090-4160 | ARIPIPRAZOLE | ARIPIPRAZOLE | A-S Medication Solutions | ANDA | Current |
| 50090-4160 | ARIPIPRAZOLE | ARIPIPRAZOLE | A-S Medication Solutions | ANDA | Current |
| 50090-4800 | ARIPIPRAZOLE | ARIPIPRAZOLE | A-S Medication Solutions | ANDA | Current |
| 50090-4800 | ARIPIPRAZOLE | ARIPIPRAZOLE | A-S Medication Solutions | ANDA | Current |
| 70518-1155 | ARIPIPRAZOLE | ARIPIPRAZOLE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1155 | ARIPIPRAZOLE | ARIPIPRAZOLE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2921 | ARIPIPRAZOLE | ARIPIPRAZOLE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2921 | ARIPIPRAZOLE | ARIPIPRAZOLE | REMEDYREPACK INC. | ANDA | Current |
| 70518-3011 | ARIPIPRAZOLE | ARIPIPRAZOLE | REMEDYREPACK INC. | ANDA | Current |
| 70934-662 | ARIPIPRAZOLE | ARIPIPRAZOLE | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 46107 | ORIG | 2016-12-09 |