Application 208708
- Type
- ANDA
- Sponsor
- RUBICON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
| 002 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
| 003 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 004 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 75MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52817-195 | Tramadol Hydrochloride | Tramadol Hydrochloride | TRUPHARMA LLC | ANDA | Current |
| 52817-195 | Tramadol Hydrochloride | Tramadol Hydrochloride | TRUPHARMA LLC | ANDA | Current |
| 52817-195 | Tramadol Hydrochloride | Tramadol Hydrochloride | TRUPHARMA LLC | ANDA | Current |
| 52817-195 | Tramadol Hydrochloride | Tramadol Hydrochloride | TRUPHARMA LLC | ANDA | Current |
| 52817-196 | Tramadol Hydrochloride | Tramadol Hydrochloride | TRUPHARMA LLC | ANDA | Current |
| 52817-196 | Tramadol Hydrochloride | Tramadol Hydrochloride | TRUPHARMA LLC | ANDA | Current |
| 52817-196 | Tramadol Hydrochloride | Tramadol Hydrochloride | TRUPHARMA LLC | ANDA | Current |
| 52817-196 | Tramadol Hydrochloride | Tramadol Hydrochloride | TRUPHARMA LLC | ANDA | Current |
| 68788-8121 | Tramadol Hydrochloride | Tramadol Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 72189-311 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | DirectRx | ANDA | Current |
| 72189-311 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | DirectRx | ANDA | Current |
| 72888-007 | Tramadol Hydrochloride | Tramadol Hydrochloride | Advagen Pharma Limited | ANDA | Current |
| 72888-007 | Tramadol Hydrochloride | Tramadol Hydrochloride | Advagen Pharma Limited | ANDA | Current |
| 72888-007 | Tramadol Hydrochloride | Tramadol Hydrochloride | Advagen Pharma Limited | ANDA | Current |
| 72888-008 | Tramadol Hydrochloride | Tramadol Hydrochloride | Advagen Pharma Limited | ANDA | Current |
| 72888-008 | Tramadol Hydrochloride | Tramadol Hydrochloride | Advagen Pharma Limited | ANDA | Current |
| 72888-008 | Tramadol Hydrochloride | Tramadol Hydrochloride | Advagen Pharma Limited | ANDA | Current |
| 72888-008 | Tramadol Hydrochloride | Tramadol Hydrochloride | Advagen Pharma Limited | ANDA | Current |
| 72888-080 | Tramadol Hydrochloride | Tramadol Hydrochloride | Advagen Pharma Limited | ANDA | Current |