Orange Book product · Brand (NDA)

PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE

PANTOPRAZOLE SODIUM

Brand (NDA)NDA 217512RX BAXTER HLTHCARE CORP

View PANTOPRAZOLE SODIUM family Open on FDA Orange Book

At a glance

Feb 14, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Feb 14, 2024
2 yr 5 mo ago
Today

Pharmaceutical detail

Active ingredient

PANTOPRAZOLE SODIUM

Strength

EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 217512

Product number

001

Marketing status

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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