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Generated: September 23, 2017

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Details for New Drug Application (NDA): 078915

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NDA 078915 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-eight 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 eighteen 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: 078915

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 078915

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POLYETHYLENE GLYCOL 3350
polyethylene glycol 3350
FOR SOLUTION;ORAL 078915 ANDA Mylan Institutional Inc. 51079-306 51079-306-30 30 POUCH in 1 CARTON (51079-306-30) > 17 g in 1 POUCH (51079-306-01)
POLYETHYLENE GLYCOL 3350
polyethylene glycol 3350
FOR SOLUTION;ORAL 078915 ANDA Cardinal Health 55154-5383 55154-5383-5 5 POUCH in 1 BAG (55154-5383-5) > 17 g in 1 POUCH

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:FOR SOLUTION;ORALStrength17GM/PACKET
Approval Date:Oct 6, 2009TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:FOR SOLUTION;ORALStrength17GM/SCOOPFUL
Approval Date:Oct 6, 2009TE:RLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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