Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210786
Company: INGENUS PHARMS LLC
Company: INGENUS PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NADOLOL | NADOLOL | 20MG | TABLET;ORAL | Discontinued | None | No | No |
| NADOLOL | NADOLOL | 40MG | TABLET;ORAL | Discontinued | None | No | No |
| NADOLOL | NADOLOL | 80MG | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/01/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/31/2024 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |