Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090600
Company: LANNETT CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLYCOLAX POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION;ORAL Discontinued None No No
GLYCOLAX POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR 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
10/06/2009 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/090600s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090600s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/07/2012 SUPPL-7 Labeling-Container/Carton Labels

Label is not available on this site.

10/21/2011 SUPPL-4 Labeling-Container/Carton Labels

Label is not available on this site.

03/08/2010 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/06/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/090600s000lbl.pdf

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