Application 202102
- 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, ORALLY DISINTEGRATING;ORAL | 10MG | No | Yes |
| 002 | ARIPIPRAZOLE | ARIPIPRAZOLE | TABLET, ORALLY DISINTEGRATING;ORAL | 15MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 13811-692 | Aripiprazole | Aripiprazole | Trigen Laboratories, LLC | ANDA | Current |
| 13811-693 | Aripiprazole | Aripiprazole | Trigen Laboratories, LLC | ANDA | Current |
| 46708-260 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-260 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-261 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-261 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-103 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-103 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-103 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-103 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-103 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-103 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-104 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-104 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-104 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-104 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-104 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-104 | Aripiprazole | Aripiprazole | Alembic Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 32179 | ORIG | 2015-04-29 |
| 19060 | ORIG | 2015-04-29 |