Assyro AI

Orange Book product · Brand (NDA)

HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%

HEPARIN SODIUM

Brand (NDA)NDA 017029DISCN FRESENIUS KABI USA

At a glance

Aug 24, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 24, 2017

    8 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HEPARIN SODIUM

Strength

40 UNITS/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 017029

Product number

021

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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.