Application 203437
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ENTACAPONE | ENTACAPONE | TABLET;ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-6822 | Entacapone | Entacapone | Major Pharmaceuticals | ANDA | Current |
| 0904-6822 | Entacapone | Entacapone | Major Pharmaceuticals | ANDA | Current |
| 0904-6822 | Entacapone | Entacapone | Major Pharmaceuticals | ANDA | Current |
| 50268-295 | Entacapone | Entacapone | AvPAK | ANDA | Current |
| 50268-295 | Entacapone | Entacapone | AvPAK | ANDA | Current |
| 50268-295 | Entacapone | Entacapone | AvPAK | ANDA | Current |
| 60687-188 | Entacapone | Entacapone | American Health Packaging | ANDA | Current |
| 60687-188 | Entacapone | Entacapone | American Health Packaging | ANDA | Current |
| 60687-188 | Entacapone | Entacapone | American Health Packaging | ANDA | Current |
| 60687-188 | Entacapone | Entacapone | American Health Packaging | ANDA | Current |
| 65862-654 | Entacapone | Entacapone | Aurobindo Pharma Limited | ANDA | Current |
| 65862-654 | Entacapone | Entacapone | Aurobindo Pharma Limited | ANDA | Current |
| 65862-654 | Entacapone | Entacapone | Aurobindo Pharma Limited | ANDA | Current |