Orange Book product · Brand (NDA)

MICAFUNGIN IN SODIUM CHLORIDE 0.9%

MICAFUNGIN SODIUM

Brand (NDA)NDA 216142RX BAXTER HLTHCARE CORP

Sep 29, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 29, 2023
2 yr 9 mo ago
Today
Patent 12403173 expires
Listed drug product patent expiration.
Dec 15, 2037
in 11 yr 8 mo

Active ingredient

MICAFUNGIN SODIUM

Strength

EQ 50MG BASE/50ML (EQ 1MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 216142

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12403173	Dec 15, 2037	in 11 yr 8 mo	Product