Assyro AI

Orange Book product · Brand (NDA)

MANNITOL 25%

MANNITOL

Brand (NDA)NDA 016269DISCN HOSPIRA

At a glance

Approved Prior to Jan 1, 1982

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

No patent or exclusivity dates are listed for this product.

Pharmaceutical detail

Active ingredient

MANNITOL

Strength

12.5GM/50ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 016269

Product number

005

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active 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

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