Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203422
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | EQ 90MG 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 |
|---|---|---|---|---|---|---|---|
| 10/16/2018 | 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 |
|---|---|---|---|---|---|
| 08/12/2020 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/12/2020 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/31/2020 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |