Application 208972
- Type
- ANDA
- Sponsor
- EPIC PHARMA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 7.5MG | No | No |
| 003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 15MG | No | No |
| 005 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 006 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 2.5MG | No | No |
| 007 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 12.5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42806-082 | Buspirone Hydrochloride | Buspirone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-083 | Buspirone Hydrochloride | Buspirone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-084 | Buspirone Hydrochloride | Buspirone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-085 | Buspirone Hydrochloride | Buspirone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 42806-086 | Buspirone Hydrochloride | Buspirone Hydrochloride | Epic Pharma, LLC | ANDA | Current |
| 55700-881 | Buspirone Hydrochloride | Buspirone Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 70518-2830 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2830 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3607 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71610-404 | Buspirone Hydrochloride | Buspirone Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |