Application 091205
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NALTREXONE HYDROCHLORIDE | NALTREXONE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16729-081 | Naltrexone Hydrochloride | Naltrexone Hydrochloride | Accord Healthcare, Inc. | ANDA | Current |
| 50090-4925 | Naltrexone Hydrochloride | Naltrexone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4925 | Naltrexone Hydrochloride | Naltrexone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4926 | Naltrexone Hydrochloride | Naltrexone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 68071-2721 | Naltrexone Hydrochloride | Naltrexone Hydrochloride | NuCare Pharmceuticals,Inc. | ANDA | Current |
| 68788-7084 | Naltrexone Hydrochloride | Naltrexone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-1146 | Naltrexone Hydrochloride | Naltrexone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1146 | Naltrexone Hydrochloride | Naltrexone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1146 | Naltrexone Hydrochloride | Naltrexone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1146 | Naltrexone Hydrochloride | Naltrexone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1146 | Naltrexone Hydrochloride | Naltrexone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-0014 | Naltrexone Hydrochloride | Naltrexone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0014 | Naltrexone Hydrochloride | Naltrexone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |