Application 214982
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DIGOXIN | DIGOXIN | TABLET;ORAL | 0.0625MG | No | No |
| 002 | DIGOXIN | DIGOXIN | TABLET;ORAL | 0.125MG | No | No |
| 003 | DIGOXIN | DIGOXIN | TABLET;ORAL | 0.25MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59651-436 | Digoxin | Digoxin | Aurobindo Pharma Limited | ANDA | Current |
| 59651-437 | Digoxin | Digoxin | Aurobindo Pharma Limited | ANDA | Current |
| 59651-438 | Digoxin | Digoxin | Aurobindo Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 71710 | ORIG | 2022-08-04 |