Last Updated: September 25, 2026

Details for New Drug Application (NDA): 078002

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NDA 078002 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 is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the caffeine citrate profile page.

Summary for 078002

Tradename:	CAFFEINE CITRATE
Applicant:	Fresenius Kabi Usa
Ingredient:	caffeine citrate
Patents:	0

Pharmacology for NDA: 078002

Physiological Effect	Central Nervous System Stimulation

Medical Subject Heading (MeSH) Categories for 078002

Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists

Suppliers and Packaging for NDA: 078002

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CAFFEINE CITRATE	caffeine citrate	SOLUTION;ORAL	078002	ANDA	Fresenius Kabi USA, LLC	63323-406	63323-406-03	5 VIAL in 1 CARTON (63323-406-03) / 3 mL in 1 VIAL (63323-406-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date:	Jan 31, 2008	TE:	AA	RLD:	No

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