Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202395
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| ZIPRASIDONE HYDROCHLORIDE | ZIPRASIDONE HYDROCHLORIDE | EQ 80MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 10/10/2013 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/07/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/02/2015 | SUPPL-1 | Labeling-Patient Package Insert |
Label is not available on this site. |