Orange Book product · Brand (NDA)

NOXAFIL POWDERMIX KIT

POSACONAZOLE

Brand (NDA)NDA 214770RX MSD MERCK CO

View POSACONAZOLE family Open on FDA Orange Book

At a glance

May 31, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
May 31, 2021
5 yr 2 mo ago
Today
Exclusivity ends · I-984
New indication exclusivity (3 years)
Jan 27, 2029
in 2 yr 8 mo

Pharmaceutical detail

Active ingredient

POSACONAZOLE

Strength

300MG

Dosage form

FOR SUSPENSION, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 214770

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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 (1)

I-984New indication 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.

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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