Assyro AI

Orange Book product · Brand (NDA)

PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE

Brand (NDA)NDA 207026RX VANTIVE US HLTHCARE

At a glance

Jan 13, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 13, 2015

    11 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE

Strength

N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML)

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 207026

Product number

002

Marketing status

RX

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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.