Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205153
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Discontinued | None | No | No |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Discontinued | None | No | No |
| DESIPRAMINE HYDROCHLORIDE | DESIPRAMINE HYDROCHLORIDE | 150MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/28/2016 | 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 |
|---|---|---|---|---|---|
| 04/16/2019 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |