Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073680
Company: CHARTWELL MOLECULAR
Company: CHARTWELL MOLECULAR
| 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 |
|---|---|---|---|---|---|---|---|
| 10/27/1992 | 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 |
|---|---|---|---|---|---|
| 03/14/2012 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/28/2011 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/11/2009 | SUPPL-18 | REMS-Proposal, Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/073680Orig1s018.pdf |
| 06/30/2009 | SUPPL-17 | Labeling, REMS-Proposal |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/073680Orig1s017.pdf |
| 01/29/2014 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 12/21/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 03/15/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 05/25/2005 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 12/06/2002 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 07/05/2001 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 06/27/2001 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 11/24/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 04/22/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/05/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 10/26/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/11/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |