Application 213899
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VIGABATRIN | VIGABATRIN | FOR SOLUTION;ORAL | 500MG/PACKET | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59651-366 | Vigabatrin | Vigabatrin | Aurobindo Pharma Limited | ANDA | Current |
| 59651-366 | Vigabatrin | Vigabatrin | Aurobindo Pharma Limited | ANDA | Current |
| 59651-366 | Vigabatrin | Vigabatrin | Aurobindo Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76261 | ORIG | 2023-11-03 |