Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210482
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 10/29/2019 | 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 |
|---|---|---|---|---|---|
| 01/22/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |