Assyro AI

Orange Book product · Brand (NDA)

FLUOTHANE

HALOTHANE

Brand (NDA)NDA 011338DISCN WYETH AYERST

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

HALOTHANE

Strength

99.99% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

LIQUID

Route

INHALATION

TE code

Not listed

Application

NDA 011338

Product number

001

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.