Assyro AI

Orange Book product · Brand (NDA)

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

HEPARIN SODIUM

Brand (NDA)NDA 019952TE APRX B BRAUN

At a glance

Jul 20, 1992

Approved

Brand (NDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 20, 1992

    34 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HEPARIN SODIUM

Strength

5,000 UNITS/100ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

NDA 019952

Product number

004

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.