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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091077
Company: NOVEL LABS INC

Products on ANDA 091077

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091077

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.

Labels for ANDA 091077

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

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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	202071	ELYSIUM
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	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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