Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073680
Company: LANNETT CO INC
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-Package Insert, Labeling-Medication Guide

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.

03/15/2007 SUPPL-11 Labeling

Label is not available on this site.

05/25/2005 SUPPL-10 Labeling

Label is not available on this site.

12/06/2002 SUPPL-8 Labeling

Label is not available on this site.

07/05/2001 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/27/2001 SUPPL-6 Labeling

Label is not available on this site.

11/24/1999 SUPPL-5 Labeling

Label is not available on this site.

04/22/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/05/1995 SUPPL-3 Labeling

Label is not available on this site.

10/26/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/11/1994 SUPPL-1 Labeling

Label is not available on this site.

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