Drugs@FDA: FDA-Approved Drugs
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. |
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02/28/2011 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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09/11/2009 | SUPPL-18 | Labeling, REMS-Proposal |
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 | REMS-Proposal, Labeling |
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. |
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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. |