Orange Book product · Brand (NDA)

POTASSIUM PHOSPHATES

POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

Brand (NDA)NDA 212121DISCN CMP DEV LLC

Sep 19, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 19, 2019
6 yr 10 mo ago
Today
Patent 10632150 expires
Listed drug product patent expiration.
Apr 19, 2039
in 13 yr

Active ingredient

POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

Strength

4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 212121

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

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

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10632150	Apr 19, 2039	in 13 yr	ProductU-2789