Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078374
Company: NORTHSTAR HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Discontinued None No No
METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE EQ 10MG 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
11/30/2007 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
11/30/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

08/19/2013 SUPPL-7 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

08/19/2013 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

02/28/2011 SUPPL-5 Labeling-Package Insert, Labeling-Container/Carton Labels Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/078374Orig1s005.pdf
02/28/2011 SUPPL-4 Labeling-Medication Guide, Labeling-Container/Carton Labels Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/078374Orig1s004.pdf
03/30/2010 SUPPL-3 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/078374Orig1s003.pdf

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