Application 204895
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GALANTAMINE HYDROBROMIDE | GALANTAMINE HYDROBROMIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 8MG BASE | No | No |
| 002 | GALANTAMINE HYDROBROMIDE | GALANTAMINE HYDROBROMIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 16MG BASE | No | No |
| 003 | GALANTAMINE HYDROBROMIDE | GALANTAMINE HYDROBROMIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 24MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65862-744 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-744 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-744 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-744 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-744 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-744 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-744 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-745 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-745 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-745 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-745 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-745 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-745 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-745 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-746 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-746 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-746 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-746 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-746 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-746 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-746 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |