Application 077645
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZONISAMIDE | ZONISAMIDE | CAPSULE;ORAL | 100MG | No | No |
| 002 | ZONISAMIDE | ZONISAMIDE | CAPSULE;ORAL | 25MG | No | No |
| 003 | ZONISAMIDE | ZONISAMIDE | CAPSULE;ORAL | 50MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55111-288 | Zonisamide | Zonisamide | Dr. Reddy's Laboratories | ANDA | Current |
| 55111-402 | Zonisamide | Zonisamide | Dr. Reddy's Laboratories | ANDA | Current |
| 55111-403 | Zonisamide | Zonisamide | Dr. Reddy's Laboratories | ANDA | Current |
| 59651-378 | Zonisamide | Zonisamide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-378 | Zonisamide | Zonisamide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-378 | Zonisamide | Zonisamide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-379 | Zonisamide | Zonisamide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-379 | Zonisamide | Zonisamide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-379 | Zonisamide | Zonisamide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-380 | Zonisamide | Zonisamide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-380 | Zonisamide | Zonisamide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-380 | Zonisamide | Zonisamide | Aurobindo Pharma Limited | ANDA | Current |
| 70518-3224 | Zonisamide | Zonisamide | REMEDYREPACK INC. | ANDA | Current |
| 70518-3224 | Zonisamide | Zonisamide | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 24164 | ORIG | 2008-02-01 |
| 9072 | ORIG | 2005-12-28 |