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Details for New Drug Application (NDA): 020793

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NDA 020793 describes CAFCIT, which is a drug marketed by West-ward Pharms Int 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 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: 020793

Tradename:
CAFCIT
Applicant:
West-ward Pharms Int
Ingredient:
caffeine citrate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 020793

Ingredient-typeXanthines
Physiological EffectCentral Nervous System Stimulation

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 West-Ward Pharmaceutical Corp. 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;ORAL 020793 NDA West-Ward Pharmaceutical Corp. 0641-6164 0641-6164-10 10 VIAL in 1 BOX (0641-6164-10) > 3 mL in 1 VIAL (0641-6164-01)

Summary 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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date:Apr 12, 2000TE:AARLD:Yes


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