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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091077
Company: NOVEL LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter 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/2009/091077s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/091077s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/03/2020 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

06/27/2011 SUPPL-3 Labeling-Container/Carton Labels

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/2009/091077s000lbl.pdf

POLYETHYLENE GLYCOL 3350

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

FOR SOLUTION;ORAL; 17GM/SCOOPFUL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
MIRALAX POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter Yes 022015 BAYER HEALTHCARE LLC
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 202850 ANI PHARMS
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 214990 ANNORA PHARMA
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 209017 AUROBINDO PHARMA LTD
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 090812 LGM PHARMA
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 078915 MYLAN
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 091077 NOVEL LABS INC
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 202071 NOVELGENIX THERAPS
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 206105 NUVO PHARMS INC
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 090685 PERRIGO R AND D
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 079214 STRIDES PHARMA
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 203928 STRIDES PHARMA
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