Skip to content
Application 213375
- Type
- ANDA
- Sponsor
- ALKEM LABS 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 |
|---|
| 67877-674 | VIGABATRIN | VIGABATRIN | Ascend Laboratories, LLC | ANDA | Current |
| 67877-674 | VIGABATRIN | VIGABATRIN | Ascend Laboratories, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76255 | ORIG | 2023-11-03 |