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Orange Book product · Generic (ANDA)

MICAFUNGIN SODIUM

MICAFUNGIN SODIUM

Generic (ANDA)ANDA 207344TE APRX FRESENIUS KABI USA
View MICAFUNGIN SODIUM familyOpen on FDA Orange Book

At a glance

May 17, 2019

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 17, 2019

    7 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

MICAFUNGIN SODIUM

Strength

EQ 50MG BASE/VIAL

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

AP

Application

ANDA 207344

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of MICAFUNGIN SODIUM

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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