Assyro AI

Orange Book product · Brand (NDA)

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

HEPARIN SODIUM

Brand (NDA)NDA 018916RX HOSPIRA

At a glance

Jan 31, 1984

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 31, 1984

    43 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

HEPARIN SODIUM

Strength

5,000 UNITS/100ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 018916

Product number

007

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.