Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071402
Company: ANI PHARMS
Company: ANI PHARMS
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 | 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 |
---|---|---|---|---|---|---|---|
06/25/1993 | 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 |
---|---|---|---|---|---|
07/28/2015 | SUPPL-12 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
07/31/2012 | SUPPL-11 | Labeling-Medication Guide, REMS-Modified |
Label is not available on this site. |
||
02/28/2011 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
03/31/2010 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
09/16/2009 | SUPPL-8 | Labeling, REMS-Modified |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/071402Orig1s008.pdf |
06/30/2009 | SUPPL-7 | Labeling, REMS-Proposal, REMS-Modified |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/071402Orig1s007.pdf |
10/28/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
12/16/2014 | SUPPL-5 | 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 |