Orange Book product · Brand (NDA)

PREPOPIK

CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

Brand (NDA)NDA 202535DISCN FERRING PHARMS INC

View CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE family Open on FDA Orange Book

At a glance

Jul 16, 2012

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Jul 16, 2012
14 yr 2 mo ago
Today
Patent 8450338 expires
Listed drug product patent expiration.
Oct 10, 2028
in 2 yr 4 mo
Patent 8481083 expires
Listed drug product patent expiration.
Oct 10, 2028
in 2 yr 4 mo

Pharmaceutical detail

Active ingredient

CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

Strength

12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

FOR SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 202535

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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 (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8450338	Oct 10, 2028	in 2 yr 4 mo	Product
8481083	Oct 10, 2028	in 2 yr 4 mo	Product

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