Drugs@FDA: FDA-Approved Drugs
Company: GENUS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE | EQ 5MG BASE/5ML | SOLUTION;ORAL | Prescription | AA | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/28/1991 | 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 |
---|---|---|---|---|---|
01/31/2014 | SUPPL-16 | Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
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09/10/2012 | SUPPL-15 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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01/28/2014 | SUPPL-14 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
02/28/2011 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
02/28/2011 | SUPPL-12 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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09/15/2009 | SUPPL-11 | Labeling, REMS-Proposal |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/072744Orig1s011.pdf |
07/02/2009 | SUPPL-10 | REMS-Proposal, Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/072744Orig1s010.pdf |
06/27/2002 | SUPPL-6 | Labeling |
Label is not available on this site. |
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05/12/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
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05/20/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
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09/29/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |
METOCLOPRAMIDE HYDROCHLORIDE
SOLUTION;ORAL; EQ 5MG BASE/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE | EQ 5MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 071402 | ANI PHARMS |
METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE | EQ 5MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 072744 | GENUS |