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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 090064

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NDA 090064 describes CAFFEINE CITRATE, which is a drug marketed by Am Regent, Eugia Pharma, Exela Pharma Science, Fresenius Kabi Usa, Micro Labs, Sagent Pharms, Sun Pharm, and Exela Pharma, and is included in thirteen NDAs. It is available from seven suppliers. Additional details are available on the CAFFEINE CITRATE profile page.

The generic ingredient in CAFFEINE CITRATE is caffeine citrate. There are eleven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the caffeine citrate profile page.

Summary for 090064

Tradename:	CAFFEINE CITRATE
Applicant:	Am Regent
Ingredient:	caffeine citrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 090064

Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date:	Nov 20, 2009	TE:		RLD:	No

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