Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203803
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, 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 |
|---|---|---|---|---|---|---|---|
| 04/29/2016 | 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 |
|---|---|---|---|---|---|
| 10/30/2019 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |