Assyro AI

Orange Book product · Brand (NDA)

CAFCIT

CAFFEINE CITRATE

Brand (NDA)NDA 020793TE APRX HIKMA

At a glance

Sep 21, 1999

Approved

Brand (NDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 21, 1999

    27 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CAFFEINE CITRATE

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

AP

Application

NDA 020793

Product number

001

Marketing status

RX

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.

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.