Assyro AI

Orange Book product · Brand (NDA)

MACUGEN

PEGAPTANIB SODIUM

Brand (NDA)NDA 021756DISCN BAUSCH AND LOMB INC

At a glance

Dec 17, 2004

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 17, 2004

    21 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PEGAPTANIB SODIUM

Strength

EQ 0.3MG ACID/0.09ML

Dosage form

INJECTABLE

Route

INTRAVITREAL

TE code

Not listed

Application

NDA 021756

Product number

001

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.