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Julphar
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US Army
Healthtrust
AstraZeneca
Johnson and Johnson
UBS
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Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019603

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NDA 019603 describes MANNITOL 5% IN PLASTIC CONTAINER, which is a drug marketed by B Braun and Icu Medical Inc and is included in two NDAs. It is available from two suppliers. Additional details are available on the MANNITOL 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in MANNITOL 5% IN PLASTIC CONTAINER is mannitol. There are eighteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the mannitol profile page.
Summary for 019603
Tradename:MANNITOL 5% IN PLASTIC CONTAINER
Applicant:Icu Medical Inc
Ingredient:mannitol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019603
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 019603
Suppliers and Packaging for NDA: 019603
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MANNITOL 10% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 019603 NDA Hospira, Inc. 0409-7714 N 0409-7714-03
MANNITOL 10% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 019603 NDA Hospira, Inc. 0409-7715 N 0409-7715-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5GM/100ML
Approval Date:Jan 8, 1987TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10GM/100ML
Approval Date:Jan 8, 1987TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength15GM/100ML
Approval Date:Jan 8, 1990TE:APRLD:No

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Argus Health
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