Application 201889
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RASAGILINE MESYLATE | RASAGILINE MESYLATE | TABLET;ORAL | EQ 0.5MG BASE | No | No |
| 002 | RASAGILINE MESYLATE | RASAGILINE MESYLATE | TABLET;ORAL | EQ 1MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-770 | Rasagiline | Rasagiline | NorthStar RxLLC | ANDA | Current |
| 16714-770 | Rasagiline | Rasagiline | NorthStar RxLLC | ANDA | Current |
| 16714-771 | Rasagiline | Rasagiline | NorthStar RxLLC | ANDA | Current |
| 16714-771 | Rasagiline | Rasagiline | NorthStar RxLLC | ANDA | Current |
| 67877-259 | Rasagiline | Rasagiline | Ascend Laboratories, LLC | ANDA | Current |
| 67877-259 | Rasagiline | Rasagiline | Ascend Laboratories, LLC | ANDA | Current |
| 67877-259 | Rasagiline | Rasagiline | Ascend Laboratories, LLC | ANDA | Current |
| 67877-259 | Rasagiline | Rasagiline | Ascend Laboratories, LLC | ANDA | Current |
| 67877-260 | Rasagiline | Rasagiline | Ascend Laboratories, LLC | ANDA | Current |
| 67877-260 | Rasagiline | Rasagiline | Ascend Laboratories, LLC | ANDA | Current |
| 67877-260 | Rasagiline | Rasagiline | Ascend Laboratories, LLC | ANDA | Current |
| 67877-260 | Rasagiline | Rasagiline | Ascend Laboratories, LLC | ANDA | Current |