Application 204309
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PHENYTOIN SODIUM | PHENYTOIN SODIUM | CAPSULE;ORAL | 100MG EXTENDED | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-3142 | Extended Phenytoin Sodium | Phenytoin Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-3165 | Extended Phenytoin Sodium | Phenytoin Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-3165 | Extended Phenytoin Sodium | Phenytoin Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-3165 | Extended Phenytoin Sodium | Phenytoin Sodium | A-S Medication Solutions | ANDA | Current |
| 65862-692 | Extended Phenytoin Sodium | Phenytoin Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-692 | Extended Phenytoin Sodium | Phenytoin Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-692 | Extended Phenytoin Sodium | Phenytoin Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-692 | Extended Phenytoin Sodium | Phenytoin Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-692 | Extended Phenytoin Sodium | Phenytoin Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 68788-6968 | Extended Phenytoin Sodium | Phenytoin Sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-2227 | Extended Phenytoin Sodium | Phenytoin Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2227 | Extended Phenytoin Sodium | Phenytoin Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2227 | Extended Phenytoin Sodium | Phenytoin Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2227 | Extended Phenytoin Sodium | Phenytoin Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2227 | Extended Phenytoin Sodium | Phenytoin Sodium | REMEDYREPACK INC. | ANDA | Current |
| 71335-1349 | Extended Phenytoin Sodium | Phenytoin Sodium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1349 | Extended Phenytoin Sodium | Phenytoin Sodium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1349 | Extended Phenytoin Sodium | Phenytoin Sodium | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 10322 | ORIG | 2015-06-12 |