Application 207098
- Type
- ANDA
- Sponsor
- TARO PHARM INDS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ILOPERIDONE | ILOPERIDONE | TABLET;ORAL | 1MG | No | No |
| 002 | ILOPERIDONE | ILOPERIDONE | TABLET;ORAL | 2MG | No | No |
| 003 | ILOPERIDONE | ILOPERIDONE | TABLET;ORAL | 4MG | No | No |
| 004 | ILOPERIDONE | ILOPERIDONE | TABLET;ORAL | 6MG | No | No |
| 005 | ILOPERIDONE | ILOPERIDONE | TABLET;ORAL | 8MG | No | No |
| 006 | ILOPERIDONE | ILOPERIDONE | TABLET;ORAL | 10MG | No | No |
| 007 | ILOPERIDONE | ILOPERIDONE | TABLET;ORAL | 12MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51672-4178 | Iloperidone | Iloperidone | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4179 | Iloperidone | Iloperidone | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4180 | Iloperidone | Iloperidone | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4181 | Iloperidone | Iloperidone | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4182 | Iloperidone | Iloperidone | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4183 | Iloperidone | Iloperidone | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4184 | Iloperidone | Iloperidone | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4213 | Iloperidone | Iloperidone | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 74207 | ORIG | 2023-05-10 |