Application 077328
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RISPERIDONE | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 0.5MG | No | No |
| 002 | RISPERIDONE | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 1MG | No | No |
| 003 | RISPERIDONE | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 2MG | No | No |
| 004 | RISPERIDONE | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 3MG | No | No |
| 005 | RISPERIDONE | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 4MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55111-207 | Risperidone | Risperidone | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-207 | Risperidone | Risperidone | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-208 | Risperidone | Risperidone | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-208 | Risperidone | Risperidone | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-209 | Risperidone | Risperidone | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-209 | Risperidone | Risperidone | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-470 | Risperidone | Risperidone | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-470 | Risperidone | Risperidone | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-471 | Risperidone | Risperidone | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-471 | Risperidone | Risperidone | Dr. Reddy's Laboratories Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 18460 | ORIG | 2009-03-19 |