Drugs@FDA: FDA-Approved Drugs
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 06/15/1993 | 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 |
|---|---|---|---|---|---|
| 07/16/2019 | SUPPL-44 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/10/2014 | SUPPL-41 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/28/2011 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/31/2010 | SUPPL-37 | REMS-Proposal |
Label is not available on this site. |
||
| 09/22/2014 | SUPPL-36 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/06/2009 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 01/24/2007 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 08/12/2002 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 11/13/2001 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/24/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/29/2001 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/22/1999 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 10/27/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 01/27/2000 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/26/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1996 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/25/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/10/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/18/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
METOCLOPRAMIDE HYDROCHLORIDE
TABLET;ORAL; EQ 5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 071250 | IMPAX LABS INC |
| METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 078807 | IPCA LABS LTD |
| METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 077878 | STRIDES PHARMA |
| METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 072801 | TEVA |
| REGLAN | METOCLOPRAMIDE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | Yes | AB | 017854 | ANI PHARMS |