Treats apnea of prematurity. ANDA 77997, held by Fresenius Kabi USA. Caffeine Citrate.
As of Nov 15, 2026, ANDA 77997 (Caffeine Citrate), held by Fresenius Kabi USA, was first approved by FDA on Jul 20, 2007, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Caffeine citrate injection is indicated for the treatment of apnea of prematurity.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 20, 2007 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Caffeine CitrateEQ 30MG BASE/3ML (EQ 10MG BASE/ML) · solution;intravenous | Caffeine Citrate | Rx |
| Sep 16, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 23, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jul 20, 2007 | 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
