Application 201893
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NADOLOL | NADOLOL | TABLET;ORAL | 40MG | No | No |
| 002 | NADOLOL | NADOLOL | TABLET;ORAL | 80MG | No | No |
| 003 | NADOLOL | NADOLOL | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59651-251 | Nadolol | Nadolol | Aurobindo Pharma Limited | ANDA | Current |
| 59651-251 | Nadolol | Nadolol | Aurobindo Pharma Limited | ANDA | Current |
| 59651-252 | Nadolol | Nadolol | Aurobindo Pharma Limited | ANDA | Current |
| 59651-252 | Nadolol | Nadolol | Aurobindo Pharma Limited | ANDA | Current |
| 59651-589 | Nadolol | Nadolol | Aurobindo Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9935 | ORIG | 2015-09-18 |