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Application 078269
- Type
- ANDA
- Sponsor
- RISING
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 0.25MG | No | No |
| 002 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 0.5MG | No | No |
| 003 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 1MG | No | No |
| 004 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 2MG | No | No |
| 005 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 3MG | No | No |
| 006 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 4MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 13107-119 | Risperidone | Risperidone | Aurolife Pharma LLC | ANDA | Current |
| 13107-120 | Risperidone | Risperidone | Aurolife Pharma LLC | ANDA | Current |
| 13107-121 | Risperidone | Risperidone | Aurolife Pharma LLC | ANDA | Current |
| 13107-122 | Risperidone | Risperidone | Aurolife Pharma LLC | ANDA | Current |
| 13107-123 | Risperidone | Risperidone | Aurolife Pharma LLC | ANDA | Current |
| 13107-124 | Risperidone | Risperidone | Aurolife Pharma LLC | ANDA | Current |
| 57237-226 | Risperidone | Risperidone | Citron Pharma LLC | ANDA | Current |
| 57237-227 | Risperidone | Risperidone | Citron Pharma LLC | ANDA | Current |
| 57237-228 | Risperidone | Risperidone | Citron Pharma LLC | ANDA | Current |
| 57237-229 | Risperidone | Risperidone | Citron Pharma LLC | ANDA | Current |
| 57237-230 | Risperidone | Risperidone | Citron Pharma LLC | ANDA | Current |
| 57237-231 | Risperidone | Risperidone | Citron Pharma LLC | ANDA | Current |
| 65862-119 | Risperidone | Risperidone | Aurobindo Pharma Limited | ANDA | Current |
| 65862-120 | Risperidone | Risperidone | Aurobindo Pharma Limited | ANDA | Current |
| 65862-121 | Risperidone | Risperidone | Aurobindo Pharma Limited | ANDA | Current |
| 65862-122 | Risperidone | Risperidone | Aurobindo Pharma Limited | ANDA | Current |
| 65862-123 | Risperidone | Risperidone | Aurobindo Pharma Limited | ANDA | Current |
| 65862-124 | Risperidone | Risperidone | Aurobindo Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 23900 | ORIG | 2008-11-25 |