Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010585
Company: MERCK
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LERITINE | ANILERIDINE HYDROCHLORIDE | EQ 25MG 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 |
|---|---|---|---|---|---|---|---|
| 08/15/1957 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 08/18/1978 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 11/24/1975 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/31/1975 | SUPPL-7 | Labeling |
Label is not available on this site. |