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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090812
Company: LGM PHARMA

Products on ANDA 090812

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 090812

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/07/2009	ORIG-1	Approval				Label is not available on this site.

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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