Application 078246
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
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 | 10MG | No | No |
| 003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 15MG | No | No |
| 004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 005 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 7.5MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-6188 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 55111-472 | Buspirone Hydrochloride | Buspirone Hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-473 | Buspirone Hydrochloride | Buspirone Hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-474 | Buspirone Hydrochloride | Buspirone Hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-475 | Buspirone Hydrochloride | Buspirone Hydrochloride | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 59651-389 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-389 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-390 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-390 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-391 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-391 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-392 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-392 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-393 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-393 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 71335-2073 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-2081 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-2193 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |