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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 077304

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NDA 077304 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 077304

Tradename:	CAFFEINE CITRATE
Applicant:	Exela Pharma
Ingredient:	caffeine citrate
Patents:	0

Pharmacology for NDA: 077304

Physiological Effect	Central Nervous System Stimulation

Medical Subject Heading (MeSH) Categories for 077304

Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists

Suppliers and Packaging for NDA: 077304

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CAFFEINE CITRATE	caffeine citrate	SOLUTION;ORAL	077304	ANDA	Exela Pharma Sciences, LLC	51754-0501	51754-0501-2	5 VIAL in 1 CARTON (51754-0501-2) / 3 mL in 1 VIAL
CAFFEINE CITRATE	caffeine citrate	SOLUTION;ORAL	077304	ANDA	Exela Pharma Sciences, LLC	51754-0501	51754-0501-3	10 VIAL in 1 CARTON (51754-0501-3) / 3 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date:	Sep 21, 2006	TE:	AA	RLD:	No

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