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Generated: April 26, 2017

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Details for New Drug Application (NDA): 090812

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NDA 090812 describes POLYETHYLENE GLYCOL 3350, which is a drug marketed by Nuvo Pharm Inc, Nexgen Pharma Inc, Nexgen Pharma, Par Pharm, Mylan, Strides Pharma, Breckenridge Pharm, Teva Pharms, Ani Pharms Inc, Paddock Llc, Raritan Pharms Inc, Novel Labs Inc, and Perrigo R And D, and is included in fifteen NDAs. It is available from sixty-four suppliers. Additional details are available on the POLYETHYLENE GLYCOL 3350 profile page.

The generic ingredient in POLYETHYLENE GLYCOL 3350 is polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous. There are four hundred and seventeen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous profile page.

Summary for NDA: 090812

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 090812

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POLYETHYLENE GLYCOL 3350
polyethylene glycol 3350
FOR SOLUTION;ORAL 090812 ANDA Nexgen Pharma, Inc. 0722-7116 0722-7116-01 7 d in 1 BOTTLE (0722-7116-01)
POLYETHYLENE GLYCOL 3350
polyethylene glycol 3350
FOR SOLUTION;ORAL 090812 ANDA Nexgen Pharma, Inc. 0722-7116 0722-7116-02 14 d in 1 BOTTLE (0722-7116-02)

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:FOR SOLUTION;ORALStrength17GM/SCOOPFUL
Approval Date:Oct 7, 2009TE:RLD:No


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