Treats apnea of prematurity. ANDA 77304, held by Exela Pharma. Caffeine Citrate.
As of Nov 15, 2026, ANDA 77304 (Caffeine Citrate), held by Exela Pharma, was first approved by FDA on Sep 21, 2006, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Caffeine citrate injection and caffeine citrate oral solution are indicated for the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 21, 2006 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Caffeine CitrateEQ 30MG BASE/3ML (EQ 10MG BASE/ML) · solution;oral | Caffeine Citrate | Rx |
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
