Last Updated: September 25, 2026

Details for New Drug Application (NDA): 090077

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NDA 090077 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 090077

Tradename:	CAFFEINE CITRATE
Applicant:	Sun Pharm
Ingredient:	caffeine citrate
Patents:	0

Pharmacology for NDA: 090077

Physiological Effect	Central Nervous System Stimulation

Medical Subject Heading (MeSH) Categories for 090077

Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists

Suppliers and Packaging for NDA: 090077

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CAFFEINE CITRATE	caffeine citrate	SOLUTION;INTRAVENOUS	090077	ANDA	Sun Pharmaceutical Industries, Inc.	47335-289	47335-289-27	1 VIAL, SINGLE-DOSE in 1 CARTON (47335-289-27) / 3 mL in 1 VIAL, SINGLE-DOSE (47335-289-26)

Profile for product number 001

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

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