Caffeine Citrate

Treats apnea of prematurity. ANDA 207400, held by Micro Labs. Caffeine Citrate.

As of Nov 15, 2026, ANDA 207400 (Caffeine Citrate), held by Micro Labs, was first approved by FDA on Dec 14, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 14, 2017
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Caffeine citrate injection is indicated for the treatment of apnea of prematurity.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Dec 14, 2017	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Caffeine CitrateEQ 30MG BASE/3ML (EQ 10MG BASE/ML) · solution;intravenous	Caffeine Citrate	Rx

All 4 submissions, including labeling and manufacturing supplements


Nov 12, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Nov 12, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Nov 12, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Dec 14, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 207400
Drugs@FDA: Overview at FDA
Company: Micro Labs Limited

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters