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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019826

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NDA 019826 describes THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by B Braun and is included in two NDAs. It is available from one supplier. Additional details are available on the THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER is theophylline. There are thirty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 019826
Tradename:THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:B Braun
Ingredient:theophylline
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 019826
Ingredient-typeXanthines
Suppliers and Packaging for NDA: 019826
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER theophylline INJECTABLE;INJECTION 019826 NDA B. Braun Medical Inc. 0264-9554 N 0264-9554-10
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER theophylline INJECTABLE;INJECTION 019826 NDA B. Braun Medical Inc. 0264-9554 N 0264-9554-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/100ML
Approval Date:Aug 14, 1992TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/100ML
Approval Date:Aug 14, 1992TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength160MG/100ML
Approval Date:Aug 14, 1992TE:APRLD:Yes

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