Treats apnea of prematurity. ANDA 213202, held by Micro Labs. Caffeine Citrate.
As of Nov 15, 2026, ANDA 213202 (Caffeine Citrate), held by Micro Labs, was first approved by FDA on Dec 16, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Caffeine citrate is indicated for the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 16, 2019 | Original application | Approved | None posted |
| 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
