Treats apnea of prematurity. ANDA 205013, held by Eugia Pharma. Caffeine Citrate.
As of Nov 15, 2026, ANDA 205013 (Caffeine Citrate), held by Eugia Pharma, was first approved by FDA on Sep 22, 2015, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Caffeine citrate injection, USP is indicated for the treatment of apnea of prematurity.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 22, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Caffeine CitrateEQ 30MG BASE/3ML (EQ 10MG BASE/ML) · solution;intravenous | Caffeine Citrate | Discontinued |
| Apr 24, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 22, 2015 | Original application | Approved | None posted |
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
