Assyro AI

Orange Book product · Brand (NDA)

PAMIDRONATE DISODIUM

PAMIDRONATE DISODIUM

Brand (NDA)NDA 021113TE AP1RX HIKMA
View PAMIDRONATE DISODIUM familyOpen on FDA Orange Book

At a glance

Mar 04, 2002

Approved

Brand (NDA)

Application

AP1

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 04, 2002

    24 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PAMIDRONATE DISODIUM

Strength

30MG/10ML (3MG/ML)

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP1

Application

NDA 021113

Product number

001

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

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