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Orange Book product · Brand (NDA)

MYFORTIC

MYCOPHENOLATE SODIUM

Brand (NDA)NDA 050791TE ABRX NOVARTIS
View MYCOPHENOLATE SODIUM familyOpen on FDA Orange Book

At a glance

Feb 27, 2004

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 27, 2004

    22 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

MYCOPHENOLATE SODIUM

Strength

EQ 180MG BASE

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

TE code

AB

Application

NDA 050791

Product number

001

Marketing status

RX

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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