Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203683
Company: WATSON LABS INC
Company: WATSON LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 11/27/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203683Orig1s000Ltr.pdf |