Viewing data from:

Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

MIRALAX

NDA

Tentative Approval

POLYETHYLENE GLYCOL 3350 | N020698 | BRAINTREE

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

3 letters from Drugs@FDA

Date	Submission	Document
Aug 10, 2004	SUPPL -9	View Letter (PDF)
Jun 9, 2004	SUPPL -4	View Letter (PDF)
Feb 18, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 17GM/SCOOPFUL

▴

FOR SOLUTION; ORAL | Approved: 1999-02-18 00:00:00

No patent or exclusivity listings for this strength.