Application 204111
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-783 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-783 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-783 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-783 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-784 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-784 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-784 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-784 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-785 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-785 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-785 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-785 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-785 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-786 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-786 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-786 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-786 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-787 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-787 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-787 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-787 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-788 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-788 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-788 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 16714-788 | Aripiprazole | Aripiprazole | NorthStar RxLLC | ANDA | Current |
| 33342-122 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-122 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-122 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-122 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-122 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-123 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-123 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-123 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-123 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-123 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-124 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-124 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-124 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-124 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-124 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-125 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-125 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-125 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-125 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-125 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-126 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-126 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-126 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-126 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-126 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-127 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-127 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-127 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-127 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-127 | Aripiprazole | Aripiprazole | Macleods Pharmaceuticals Limited | ANDA | Current |
| 50090-4381 | Aripiprazole | Aripiprazole | A-S Medication Solutions | ANDA | Current |
| 50090-4817 | Aripiprazole | Aripiprazole | A-S Medication Solutions | ANDA | Current |
| 50090-4817 | Aripiprazole | Aripiprazole | A-S Medication Solutions | ANDA | Current |
| 70518-2471 | Aripiprazole | Aripiprazole | REMEDYREPACK INC. | ANDA | Current |