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Generated: September 22, 2018

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Details for New Drug Application (NDA): 016269

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NDA 016269 describes MANNITOL 5%, which is a drug marketed by B Braun, Hospira, and Icu Medical Inc, and is included in four NDAs. It is available from three suppliers. Additional details are available on the MANNITOL 5% profile page.

The generic ingredient in MANNITOL 5% is mannitol. There are eighteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the mannitol profile page.
Summary for 016269
Tradename:MANNITOL 5%
Applicant:Hospira
Ingredient:mannitol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 016269
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 016269
Suppliers and Packaging for NDA: 016269
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MANNITOL 10% mannitol INJECTABLE;INJECTION 016269 NDA Hospira, Inc. 0409-4031 0409-4031-01 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4031-01) > 50 mL in 1 VIAL, SINGLE-DOSE (0409-4031-16)
MANNITOL 15% mannitol INJECTABLE;INJECTION 016269 NDA Hospira, Inc. 0409-4031 0409-4031-01 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4031-01) > 50 mL in 1 VIAL, SINGLE-DOSE (0409-4031-16)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength5GM/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10GM/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength15GM/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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