Is Aminophylline In Sodium Chloride 0.45% In Plastic Container still available?

Aminophylline In Sodium Chloride 0.45% In Plastic Container (NDA 018924) is listed as Discontinued in the FDA Orange Book — it is no longer marketed. A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.

What is Aminophylline In Sodium Chloride 0.45% In Plastic Container's FDA application number?

Aminophylline In Sodium Chloride 0.45% In Plastic Container is approved under NDA 018924, held by Hospira.

Orange Book product · Brand (NDA)

Aminophylline In Sodium Chloride 0.45% In Plastic Container

Aminophylline

Brand (NDA)NDA 018924Discontinued Hospira

Approved

Dec 12, 1984

Application

Brand (NDA)

TE code

Not listed

Listed patents

Aminophylline In Sodium Chloride 0.45% In Plastic Container (Aminophylline) is Hospira's brand-name drug, approved by the FDA under NDA 018924 in 1984. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 48 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Dec 12, 1984
42 yr 2 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

AMINOPHYLLINE

Strength

100MG/100ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 018924

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Reference standard (RS)

Same application

Other strengths in NDA 018924

Brand + generics

Active-ingredient family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

View full Aminophylline family

Orange Book patent file

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.