Application 071026
- Type
- ANDA
- Sponsor
- FRONTIDA BIOPHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXAZEPAM | OXAZEPAM | CAPSULE;ORAL | 30MG | No | No |
| 002 | OXAZEPAM | OXAZEPAM | CAPSULE;ORAL | 10MG | No | No |
| 003 | OXAZEPAM | OXAZEPAM | CAPSULE;ORAL | 15MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52817-290 | Oxazepam | Oxazepam | TruPharma, LLC | ANDA | Current |
| 52817-290 | Oxazepam | Oxazepam | TruPharma, LLC | ANDA | Current |
| 52817-290 | Oxazepam | Oxazepam | TruPharma, LLC | ANDA | Current |
| 52817-290 | Oxazepam | Oxazepam | TruPharma, LLC | ANDA | Current |
| 52817-290 | Oxazepam | Oxazepam | TruPharma, LLC | ANDA | Current |
| 52817-290 | Oxazepam | Oxazepam | TruPharma, LLC | ANDA | Current |
| 52817-291 | Oxazepam | Oxazepam | TruPharma, LLC | ANDA | Current |
| 52817-291 | Oxazepam | Oxazepam | TruPharma, LLC | ANDA | Current |
| 52817-291 | Oxazepam | Oxazepam | TruPharma, LLC | ANDA | Current |
| 52817-291 | Oxazepam | Oxazepam | TruPharma, LLC | ANDA | Current |
| 52817-291 | Oxazepam | Oxazepam | TruPharma, LLC | ANDA | Current |
| 52817-291 | Oxazepam | Oxazepam | TruPharma, LLC | ANDA | Current |
| 52817-292 | Oxazepam | Oxazepam | TruPharma, LLC | ANDA | Current |
| 52817-292 | Oxazepam | Oxazepam | TruPharma, LLC | ANDA | Current |
| 52817-292 | Oxazepam | Oxazepam | TruPharma, LLC | ANDA | Current |
| 52817-292 | Oxazepam | Oxazepam | TruPharma, LLC | ANDA | Current |
| 71610-639 | Oxazepam | Oxazepam | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |