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POLYETHYLENE GLYCOL 3350

ANDA

POLYETHYLENE GLYCOL 3350 | A078915 | MYLAN PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain4 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

BASF CORPPOLYETHYLENE GLYCOL 3350

DMF 169462003

AVESTA PHARMA PVT LTDPOLYETHYLENE GLYCOL 3350 USP

DMF 274192013

CLARIANT CHEMICALS (HUIZHOU) LTDPOLYETHYLENE GLYCOL 3350 USP/NF

DMF 323552018

PHARCOS SPECIALITY LTDPOLYETHYLENE GLYCOL 3350 USP

DMF 413202025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 14, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 17GM/PACKET

0 patents0 exclusivities▴

FOR SOLUTION;ORAL | Approved: Oct 6, 2009

No patent or exclusivity listings for this strength.

#002 — 17GM/SCOOPFUL

0 patents0 exclusivities▾

FOR SOLUTION;ORAL | Approved: Oct 6, 2009