Caffeine Citrate

Treats apnea of prematurity. Sold as Cafcit. Every FDA application for this active ingredient: 1 branded and 13 generic.

As of Nov 14, 2026, FDA lists 14 applications for Caffeine Citrate (sold as Cafcit), first approved Sep 21, 1999, with 1 new use approved and 0 published complete response letters.

First approved: Sep 21, 1999
Applications: 14
New uses approved: 1
Complete response letters: 0
First approved in the EU: Jul 2, 2009

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of apnea of prematurity.O.P.R. Development, L.P. · designated Sep 20, 1988 · approved Sep 21, 1999

Approvals in the EU (EMA)

First approved in the EU 117 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

GencebokGennisium Pharma · Aug 19, 2020
Peyona (previously Nymusa), new substanceChiesi Farmaceutici SpA · Jul 2, 2009

Clinical Trials

20 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Acute Effects of Rhodiola Rosea and Caffeine on Mean Propulsive Velocity Loss in Resistance TrainingMuscle Fatigue (C23.888.592.612.612) · MARINA MEDINA CORRALES	Not applicable	Not yet recruiting	Nov 9, 2026
Pharmacokinetics and Placental Transfer of CaffeinePreterm Labor With Preterm Delivery, Premature Birth · Indiana University	Phase 1	Recruiting	May 6, 2026
Sublingual Caffeine on Reducing Recovery Time and Postoperative Agitation in Elderly Patients Undergoing General AnesthesiaSublingual, Caffeine · Cairo University	Not applicable	Recruiting	Apr 17, 2026
Caffeine for Infants Born at 28 to 34 Weeks Receiving Respiratory SupportPreterm Birth, Caffeine · Queen's University	Phase 2	Not yet recruiting	Mar 6, 2026
The Effect of Caffeine Therapy in Cardiovascular Stability in Preterm Neonates at Assiut University Children Hospital NICUPreterm Neonates, Apnea of Prematurity · Assiut University	—	Not yet recruiting	Dec 10, 2025
Improving Preterm Kidney Outcomes With CaffeineKidney Injury, Pre-Term · University of Wisconsin, Madison	Phase 2	Recruiting	Dec 3, 2025
Caffeine Optimization for Oxygen Saturation Index in ELBW InfantsNeonatal Apnea, Infants · University of Rochester	Phase 2	Recruiting	Oct 14, 2025
Caffeine Citrate to Improve Neonatal Outcomes.Apnea of Prematurity · University of Melbourne	Not applicable	Not yet recruiting	May 15, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Sep 21, 1999	CafcitNDA 20793 · New active ingredient	Hikma	8	Marketed
Sep 21, 2006	Caffeine CitrateANDA 77233	Exela Pharma Science	0	Marketed
Sep 21, 2006	Caffeine CitrateANDA 77304	Exela Pharma	0	Marketed
May 15, 2007	Caffeine CitrateANDA 77906	Am Regent	2	Marketed
Jul 20, 2007	Caffeine CitrateANDA 77997	Fresenius Kabi USA	2	Marketed
Jan 31, 2008	Caffeine CitrateANDA 78002	Fresenius Kabi USA	1	Marketed
Sep 30, 2009	Caffeine CitrateANDA 90077	Sun Pharm	0	Discontinued
Sep 30, 2009	Caffeine CitrateANDA 90357	Sun Pharm	0	Discontinued
Nov 20, 2009	Caffeine CitrateANDA 90064	Am Regent	0	Discontinued
Aug 29, 2012	Caffeine CitrateANDA 90827	Sagent Pharms	2	Marketed
Aug 29, 2012	Caffeine CitrateANDA 91102	Sagent Pharms	1	Marketed
Sep 22, 2015	Caffeine CitrateANDA 205013	Eugia Pharma	1	Discontinued
Dec 14, 2017	Caffeine CitrateANDA 207400	Micro Labs	3	Marketed
Dec 16, 2019	Caffeine CitrateANDA 213202	Micro Labs	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA