Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071250
Company: IMPAX LABS INC
Company: IMPAX LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE | EQ 5MG 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 |
|---|---|---|---|---|---|---|---|
| 02/03/1988 | 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 |
|---|---|---|---|---|---|
| 07/16/2019 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/05/2012 | SUPPL-34 | Labeling-Package Insert, REMS-Modified, Labeling-Medication Guide |
Label is not available on this site. |
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| 04/29/2010 | SUPPL-31 | REMS-Proposal |
Label is not available on this site. |
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| 05/23/2002 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/29/2001 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 04/18/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/05/2001 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 07/07/2000 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 09/11/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/24/1999 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 06/27/2000 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/21/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/19/1995 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 11/03/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 05/11/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/30/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 07/02/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |