Orange Book product · Brand (NDA)

NOXAFIL

POSACONAZOLE

Brand (NDA)NDA 205053DISCN MERCK SHARP DOHME

View POSACONAZOLE family Open on FDA Orange Book

At a glance

Nov 25, 2013

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Nov 25, 2013
12 yr 9 mo ago
Today
Exclusivity ends · ODE-355
Orphan-drug exclusivity (7 years)
Jun 17, 2028
in 2 yr
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Jan 27, 2029
in 2 yr 8 mo

Pharmaceutical detail

Active ingredient

POSACONAZOLE

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 205053

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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.

Marketing exclusivity (2)

ODE-355Orphan-drug exclusivity (7 years)
Jun 17, 2028
in 2 yr
NPPNew patient population exclusivity (3 years)
Jan 27, 2029
in 2 yr 8 mo

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.

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