Assyro AI

Orange Book product · Brand (NDA)

HEPARIN SODIUM

HEPARIN SODIUM

Brand (NDA)NDA 201370DISCN PFIZER

At a glance

Jul 21, 2011

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 21, 2011

    15 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HEPARIN SODIUM

Strength

10,000 UNITS/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 201370

Product number

003

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

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