Application 077494
- Type
- ANDA
- Sponsor
- PAR PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RISPERIDONE | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 0.25MG | No | No |
| 002 | RISPERIDONE | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 0.5MG | No | No |
| 003 | RISPERIDONE | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 1MG | No | No |
| 004 | RISPERIDONE | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 2MG | No | No |
| 005 | RISPERIDONE | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 3MG | No | No |
| 006 | RISPERIDONE | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 4MG | No | No |
| 007 | RISPERIDONE | RISPERIDONE | TABLET, ORALLY DISINTEGRATING; ORAL | 1MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 49884-212 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-212 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-212 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-212 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-212 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-311 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-311 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-311 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-311 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-311 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-315 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-315 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-315 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-315 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-315 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-401 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-401 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-401 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-401 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-401 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-402 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-402 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-402 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-402 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-402 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-403 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-403 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-403 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-403 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-403 | Risperidone | Risperidone | Par Pharmaceutical, Inc. | ANDA | Current |
| 50090-3589 | Risperidone | Risperidone | A-S Medication Solutions | ANDA | Current |
| 63629-2283 | Risperidone | Risperidone | Bryant Ranch Prepack | ANDA | Current |
| 63629-2283 | Risperidone | Risperidone | Bryant Ranch Prepack | ANDA | Current |
| 63629-2284 | Risperidone | Risperidone | Bryant Ranch Prepack | ANDA | Current |
| 63629-2284 | Risperidone | Risperidone | Bryant Ranch Prepack | ANDA | Current |