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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 020793


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NDA 020793 describes CAFCIT, which is a drug marketed by Hikma and is included in one NDA. It is available from one supplier. Additional details are available on the CAFCIT profile page.

The generic ingredient in CAFCIT 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 020793
Tradename:CAFCIT
Applicant:Hikma
Ingredient:caffeine citrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020793
Suppliers and Packaging for NDA: 020793
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAFCIT caffeine citrate SOLUTION;INTRAVENOUS 020793 NDA Hikma Pharmaceuticals USA Inc. 0641-6164 0641-6164-10 10 VIAL in 1 BOX (0641-6164-10) / 3 mL in 1 VIAL (0641-6164-01)
CAFCIT caffeine citrate SOLUTION;INTRAVENOUS 020793 NDA Hikma Pharmaceuticals USA Inc. 0641-6267 0641-6267-10 10 VIAL in 1 BOX (0641-6267-10) / 3 mL in 1 VIAL (0641-6267-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date:Sep 21, 1999TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrengthEQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Apr 12, 2000TE:RLD:Yes

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