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Details for New Drug Application (NDA): 090827

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NDA 090827 describes CAFFEINE CITRATE, which is a drug marketed by Fresenius Kabi Usa, Sagent Pharms, Exela Pharma Scs Llc, Luitpold, Aurobindo Pharma Ltd, Exela Pharma Science, and Sun Pharma Global, and is included in eleven 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 ten 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 NDA: 090827

Sagent Pharms
caffeine citrate

Pharmacology for NDA: 090827

Physiological EffectCentral Nervous System Stimulation

Suppliers and Packaging for NDA: 090827

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
caffeine citrate
SOLUTION;INTRAVENOUS 090827 ANDA Sagent Pharmaceuticals 25021-601 25021-601-03 1 VIAL in 1 CARTON (25021-601-03) > 3 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date:Aug 29, 2012TE:APRLD:No

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