Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076652
Company: LANNETT CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLYCOLAX POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR 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
07/02/2004 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076652_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/16/2005 SUPPL-2 Labeling

Label is not available on this site.

GLYCOLAX

FOR SOLUTION;ORAL; 17GM/SCOOPFUL
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYCOLAX POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Prescription No AA 076652 LANNETT CO INC
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Prescription No AA 077706 NEXGEN PHARMA INC
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Prescription No AA 077893 PADDOCK LLC

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