Treats apnea of prematurity. ANDA 78002, held by Fresenius Kabi USA. Caffeine Citrate.
As of Nov 15, 2026, ANDA 78002 (Caffeine Citrate), held by Fresenius Kabi USA, was first approved by FDA on Jan 31, 2008, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Caffeine citrate oral solution is indicated for the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 31, 2008 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Caffeine CitrateEQ 30MG BASE/3ML (EQ 10MG BASE/ML) · solution;oral | Caffeine Citrate | Rx |
| Sep 26, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jan 31, 2008 | 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
