Details for New Drug Application (NDA): 077233

NDA 077233 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 eight 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. Nine suppliers are listed for this compound. Additional details are available on the caffeine citrate profile page.

Summary for 077233

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

Pharmacology for NDA: 077233

Physiological Effect

Central Nervous System Stimulation

Medical Subject Heading (MeSH) Categories for 077233

Central Nervous System Stimulants

Phosphodiesterase Inhibitors

Purinergic P1 Receptor Antagonists

Suppliers and Packaging for NDA: 077233

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CAFFEINE CITRATE	caffeine citrate	SOLUTION;INTRAVENOUS	077233	ANDA	Exela Pharma Sciences, LLC	51754-0500	51754-0500-1	1 VIAL in 1 CARTON (51754-0500-1) / 3 mL in 1 VIAL
CAFFEINE CITRATE	caffeine citrate	SOLUTION;INTRAVENOUS	077233	ANDA	Exela Pharma Sciences, LLC	51754-0502	51754-0502-3	10 VIAL, SINGLE-DOSE in 1 CARTON (51754-0502-3) / 3 mL in 1 VIAL, SINGLE-DOSE (51754-0502-1)

Profile for product number 001

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

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