Details for New Drug Application (NDA): 207400

NDA 207400 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 207400

Tradename:	CAFFEINE CITRATE
Applicant:	Micro Labs
Ingredient:	caffeine citrate
Patents:	0

Pharmacology for NDA: 207400

Physiological Effect

Central Nervous System Stimulation

Medical Subject Heading (MeSH) Categories for 207400

Central Nervous System Stimulants

Phosphodiesterase Inhibitors

Purinergic P1 Receptor Antagonists

Suppliers and Packaging for NDA: 207400

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CAFFEINE CITRATE	caffeine citrate	SOLUTION;INTRAVENOUS	207400	ANDA	Micro Labs Limited	42571-244	42571-244-98	10 CARTON in 1 BOX (42571-244-98) / 1 VIAL, GLASS in 1 CARTON (42571-244-69) / 3 mL in 1 VIAL, GLASS
CAFFEINE CITRATE	caffeine citrate	SOLUTION;INTRAVENOUS	207400	ANDA	Armas Pharmaceuticals Inc.	72485-104	72485-104-01	1 VIAL, GLASS in 1 CARTON (72485-104-01) / 3 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date:	Dec 14, 2017	TE:	AP	RLD:	No

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