Application 203908
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
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 |
|---|
| 50090-2691 | Aripiprazole | Aripiprazole | A-S Medication Solutions | ANDA | Current |
| 63739-413 | Aripiprazole | Aripiprazole | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-413 | Aripiprazole | Aripiprazole | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 65862-661 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-661 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-661 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-661 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-661 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-661 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-661 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-662 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-662 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-662 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-662 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-662 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-662 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-662 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-663 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-663 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-663 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-663 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-663 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-663 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-663 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-664 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-664 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-664 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-664 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-664 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-664 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-664 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-665 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-665 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-665 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-665 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-665 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-665 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-665 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-666 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-666 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-666 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-666 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-666 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-666 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 65862-666 | Aripiprazole | Aripiprazole | Aurobindo Pharma Limited | ANDA | Current |
| 70518-0759 | Aripiprazole | Aripiprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0759 | Aripiprazole | Aripiprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-1247 | Aripiprazole | Aripiprazole | REMEDYREPACK INC. | ANDA | Current |
| 71205-392 | Aripiprazole | Aripiprazole | Proficient Rx LP | ANDA | Current |
| 71205-392 | Aripiprazole | Aripiprazole | Proficient Rx LP | ANDA | Current |
| 71205-480 | Aripiprazole | Aripiprazole | Proficient Rx LP | ANDA | Current |
| 71205-480 | Aripiprazole | Aripiprazole | Proficient Rx LP | ANDA | Current |
| 71335-1364 | Aripiprazole | Aripiprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1364 | Aripiprazole | Aripiprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1364 | Aripiprazole | Aripiprazole | Bryant Ranch Prepack | ANDA | Current |