Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074642
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 20MG | CAPSULE;ORAL | Discontinued | None | No | No |
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | 30MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/18/1996 | 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 |
|---|---|---|---|---|---|
| 01/24/2002 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 02/04/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/07/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |