Orange Book product · Brand (NDA)

THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER

THEOPHYLLINE

Brand (NDA)NDA 019211DISCN HOSPIRA INC

View THEOPHYLLINE family Open on FDA Orange Book

At a glance

Jan 20, 1988

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Jan 20, 1988
39 yr ago
Today

Pharmaceutical detail

Active ingredient

THEOPHYLLINE

Strength

320MG/100ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 019211

Product number

006

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.

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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