Application 210790
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVOMILNACIPRAN HYDROCHLORIDE | LEVOMILNACIPRAN HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 20MG BASE | No | No |
| 002 | LEVOMILNACIPRAN HYDROCHLORIDE | LEVOMILNACIPRAN HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 40MG BASE | No | No |
| 003 | LEVOMILNACIPRAN HYDROCHLORIDE | LEVOMILNACIPRAN HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 80MG BASE | No | No |
| 004 | LEVOMILNACIPRAN HYDROCHLORIDE | LEVOMILNACIPRAN HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 120MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65162-411 | Levomilnacipran | Levomilnacipran | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-411 | Levomilnacipran | Levomilnacipran | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-411 | Levomilnacipran | Levomilnacipran | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-437 | Levomilnacipran | Levomilnacipran | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-437 | Levomilnacipran | Levomilnacipran | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-437 | Levomilnacipran | Levomilnacipran | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-455 | Levomilnacipran | Levomilnacipran | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-455 | Levomilnacipran | Levomilnacipran | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-455 | Levomilnacipran | Levomilnacipran | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-960 | Levomilnacipran | Levomilnacipran | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-960 | Levomilnacipran | Levomilnacipran | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-960 | Levomilnacipran | Levomilnacipran | Amneal Pharmaceuticals LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 57965 | ORIG | 2019-03-12 |