Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071340
Company: ACTAVIS MID ATLANTIC
Company: ACTAVIS MID ATLANTIC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE | EQ 5MG BASE/5ML | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 08/18/1988 | 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 |
|---|---|---|---|---|---|
| 04/11/2003 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/30/2002 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/30/2002 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/10/2001 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 07/31/2000 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/24/2000 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 10/21/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/21/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/1996 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 09/15/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1990 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/25/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/29/1993 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 09/27/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/05/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/27/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |