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Dow
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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077997

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NDA 077997 describes CAFFEINE CITRATE, which is a drug marketed by Aurobindo Pharma Ltd, Exela Pharma Science, Fresenius Kabi Usa, Luitpold, Micro Labs, Sagent Pharms, Sun Pharma Global, and Exela Pharma Scs Llc, and is included in twelve 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 077997
Tradename:CAFFEINE CITRATE
Applicant:Fresenius Kabi Usa
Ingredient:caffeine citrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077997
Ingredient-typeXanthines
Physiological EffectCentral Nervous System Stimulation
Suppliers and Packaging for NDA: 077997
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAFFEINE CITRATE caffeine citrate SOLUTION;INTRAVENOUS 077997 ANDA Fresenius Kabi USA, LLC 63323-407 N 63323-407-03
CAFFEINE CITRATE caffeine citrate SOLUTION;INTRAVENOUS 077997 ANDA Fresenius Kabi USA, LLC 63323-407 N 63323-407-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date:Jul 20, 2007TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Colorcon
Boehringer Ingelheim
Healthtrust
Accenture
Baxter
US Department of Justice
Cerilliant
Fuji

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