Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019826

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THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER (THEOPHYLLINE)
40MG/100ML
Marketing Status: Discontinued

Active Ingredient: THEOPHYLLINE
Proprietary Name: THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 40MG/100ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019826
Product Number: 001
Approval Date: Aug 14, 1992
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER (THEOPHYLLINE)
80MG/100ML
Marketing Status: Discontinued

Active Ingredient: THEOPHYLLINE
Proprietary Name: THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 80MG/100ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019826
Product Number: 002
Approval Date: Aug 14, 1992
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER (THEOPHYLLINE)
160MG/100ML
Marketing Status: Discontinued

Active Ingredient: THEOPHYLLINE
Proprietary Name: THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 160MG/100ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019826
Product Number: 003
Approval Date: Aug 14, 1992
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER (THEOPHYLLINE)
200MG/100ML
Marketing Status: Discontinued

Active Ingredient: THEOPHYLLINE
Proprietary Name: THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 200MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019826
Product Number: 004
Approval Date: Aug 14, 1992
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER (THEOPHYLLINE)
320MG/100ML
Marketing Status: Discontinued

Active Ingredient: THEOPHYLLINE
Proprietary Name: THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 320MG/100ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019826
Product Number: 006
Approval Date: Aug 14, 1992
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER (THEOPHYLLINE)
400MG/100ML
Marketing Status: Discontinued

Active Ingredient: THEOPHYLLINE
Proprietary Name: THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 400MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019826
Product Number: 005
Approval Date: Aug 14, 1992
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information