Application 090957
- 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 | TABLET;ORAL | EQ 4MG BASE | No | No |
| 002 | GALANTAMINE HYDROBROMIDE | GALANTAMINE HYDROBROMIDE | TABLET;ORAL | EQ 8MG BASE | No | No |
| 003 | GALANTAMINE HYDROBROMIDE | GALANTAMINE HYDROBROMIDE | TABLET;ORAL | EQ 12MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 57237-049 | Galantamine | Galantamine | Rising Health, LLC | ANDA | Current |
| 57237-049 | Galantamine | Galantamine | Rising Health, LLC | ANDA | Current |
| 57237-049 | Galantamine | Galantamine | Rising Health, LLC | ANDA | Current |
| 57237-049 | Galantamine | Galantamine | Rising Health, LLC | ANDA | Current |
| 57237-050 | Galantamine | Galantamine | Rising Health, LLC | ANDA | Current |
| 57237-050 | Galantamine | Galantamine | Rising Health, LLC | ANDA | Current |
| 57237-050 | Galantamine | Galantamine | Rising Health, LLC | ANDA | Current |
| 57237-050 | Galantamine | Galantamine | Rising Health, LLC | ANDA | Current |
| 57237-051 | Galantamine | Galantamine | Rising Health, LLC | ANDA | Current |
| 57237-051 | Galantamine | Galantamine | Rising Health, LLC | ANDA | Current |
| 57237-051 | Galantamine | Galantamine | Rising Health, LLC | ANDA | Current |
| 57237-051 | Galantamine | Galantamine | Rising Health, LLC | ANDA | Current |
| 63739-708 | Galantamine | Galantamine | McKesson Corporation | ANDA | Current |
| 63739-708 | Galantamine | Galantamine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-999 | Galantamine | Galantamine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-999 | Galantamine | Galantamine | McKesson Corporation | ANDA | Current |
| 63739-999 | Galantamine | Galantamine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 65862-458 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-458 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-458 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-458 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-458 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-459 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-459 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-459 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-459 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-459 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-460 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-460 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-460 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-460 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 65862-460 | Galantamine | Galantamine | Aurobindo Pharma Limited | ANDA | Current |
| 68084-729 | Galantamine | Galantamine | American Health Packaging | ANDA | Current |
| 68084-729 | Galantamine | Galantamine | American Health Packaging | ANDA | Current |
| 68084-729 | Galantamine | Galantamine | American Health Packaging | ANDA | Current |
| 68084-729 | Galantamine | Galantamine | American Health Packaging | ANDA | Current |