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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019603

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MANNITOL 20% IN PLASTIC CONTAINER (MANNITOL)
20GM/100ML
Marketing Status: Prescription
Active Ingredient: MANNITOL
Proprietary Name: MANNITOL 20% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: N019603
Product Number: 004
Approval Date: Jan 8, 1990
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
MANNITOL 10% IN PLASTIC CONTAINER (MANNITOL)
10GM/100ML
Marketing Status: Discontinued
Active Ingredient: MANNITOL
Proprietary Name: MANNITOL 10% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019603
Product Number: 002
Approval Date: Jan 8, 1987
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
MANNITOL 15% IN PLASTIC CONTAINER (MANNITOL)
15GM/100ML
Marketing Status: Discontinued
Active Ingredient: MANNITOL
Proprietary Name: MANNITOL 15% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 15GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019603
Product Number: 003
Approval Date: Jan 8, 1990
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
MANNITOL 5% IN PLASTIC CONTAINER (MANNITOL)
5GM/100ML
Marketing Status: Discontinued
Active Ingredient: MANNITOL
Proprietary Name: MANNITOL 5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019603
Product Number: 001
Approval Date: Jan 8, 1987
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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