Application 202101
- Type
- ANDA
- Sponsor
- ALEMBIC 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 |
|---|
| 13811-679 | Aripiprazole | Aripiprazole | Trigen Laboratories, LLC | ANDA | Current |
| 13811-680 | Aripiprazole | Aripiprazole | Trigen Laboratories, LLC | ANDA | Current |
| 13811-681 | Aripiprazole | Aripiprazole | Trigen Laboratories, LLC | ANDA | Current |
| 13811-682 | Aripiprazole | Aripiprazole | Trigen Laboratories, LLC | ANDA | Current |
| 13811-683 | Aripiprazole | Aripiprazole | Trigen Laboratories, LLC | ANDA | Current |
| 13811-684 | Aripiprazole | Aripiprazole | Trigen Laboratories, LLC | ANDA | Current |
| 17856-0680 | Aripiprazole | Aripiprazole | Atlantic Biologicals Corps | ANDA | Current |
| 17856-0680 | Aripiprazole | Aripiprazole | Atlantic Biologicals Corps | ANDA | Current |
| 46708-254 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-254 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-255 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-255 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-256 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-256 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-257 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-257 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-258 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-258 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-259 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-259 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-097 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-097 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-097 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-097 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-097 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-098 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-098 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-098 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-098 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-098 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-099 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-099 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-099 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-099 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-099 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-100 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-100 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-100 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-100 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-100 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-101 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-101 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-101 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-101 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-101 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-102 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-102 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-102 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-102 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-102 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 68151-4459 | Aripiprazole | Aripiprazole | Carilion Materials Management | ANDA | Current |
| 70518-1794 | Aripiprazole | Aripiprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-1794 | Aripiprazole | Aripiprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-1822 | Aripiprazole | Aripiprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-1822 | Aripiprazole | Aripiprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-1870 | Aripiprazole | Aripiprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-1871 | Aripiprazole | Aripiprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2149 | Aripiprazole | Aripiprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2150 | Aripiprazole | Aripiprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2281 | Aripiprazole | Aripiprazole | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 40120 | ORIG | 2015-04-29 |
| 9960 | ORIG | 2015-04-29 |