Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072995
Company: ROXANE
Company: ROXANE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METOCLOPRAMIDE INTENSOL | METOCLOPRAMIDE HYDROCHLORIDE | EQ 10MG BASE/ML | CONCENTRATE;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 |
|---|---|---|---|---|---|---|---|
| 01/30/1992 | 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 |
|---|---|---|---|---|---|
| 04/01/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |