Orange Book product · Brand (NDA)

MIRALAX

POLYETHYLENE GLYCOL 3350

Brand (NDA)NDA 022015OTC BAYER HEALTHCARE LLC

View POLYETHYLENE GLYCOL 3350 family Open on FDA Orange Book

At a glance

Oct 06, 2006

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Oct 06, 2006
20 yr ago
Today

Pharmaceutical detail

Active ingredient

POLYETHYLENE GLYCOL 3350

Strength

17GM/PACKET

Dosage form

FOR SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 022015

Product number

002

Marketing status

OTC

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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