Application 078607
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-7569 | Aripiprazole | Aripiprazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 70518-1144 | Aripiprazole | Aripiprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-1144 | Aripiprazole | Aripiprazole | REMEDYREPACK INC. | ANDA | Current |