Application 202547
- Type
- ANDA
- Sponsor
- ORCHID HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARIPIPRAZOLE | ARIPIPRAZOLE | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | No | No |
| 002 | ARIPIPRAZOLE | ARIPIPRAZOLE | TABLET, ORALLY DISINTEGRATING;ORAL | 15MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42043-400 | Aripiprazole | Aripiprazole | OrchidPharma Inc | ANDA | Current |
| 42043-400 | Aripiprazole | Aripiprazole | OrchidPharma Inc | ANDA | Current |
| 42043-400 | Aripiprazole | Aripiprazole | OrchidPharma Inc | ANDA | Current |
| 42043-400 | Aripiprazole | Aripiprazole | OrchidPharma Inc | ANDA | Current |
| 42043-400 | Aripiprazole | Aripiprazole | OrchidPharma Inc | ANDA | Current |
| 42043-401 | Aripiprazole | Aripiprazole | OrchidPharma Inc | ANDA | Current |
| 42043-401 | Aripiprazole | Aripiprazole | OrchidPharma Inc | ANDA | Current |
| 42043-401 | Aripiprazole | Aripiprazole | OrchidPharma Inc | ANDA | Current |
| 42043-401 | Aripiprazole | Aripiprazole | OrchidPharma Inc | ANDA | Current |
| 42043-401 | Aripiprazole | Aripiprazole | OrchidPharma Inc | ANDA | Current |
| 69452-338 | Aripiprazole | Aripiprazole | Bionpharma Inc. | ANDA | Current |
| 69452-339 | Aripiprazole | Aripiprazole | Bionpharma Inc. | ANDA | Current |