Treats apnea of prematurity. ANDA 90827, held by Sagent Pharms. Caffeine Citrate.
As of Nov 15, 2026, ANDA 90827 (Caffeine Citrate), held by Sagent Pharms, was first approved by FDA on Aug 29, 2012, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Caffeine citrate is indicated for the treatment of apnea of prematurity.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 29, 2012 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Caffeine CitrateEQ 30MG BASE/3ML (EQ 10MG BASE/ML) · solution;intravenous | Caffeine Citrate | Rx |
| Jan 2, 2017 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 25, 2013 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 29, 2012 | 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
