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Serving leading biopharmaceutical companies globally:

Merck
McKesson
Queensland Health
Mallinckrodt
Julphar
US Army
Argus Health
US Department of Justice
Johnson and Johnson
Moodys

Generated: January 18, 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 seventeen drug master file entries for this compound. Seven 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 0409-7714-03 12 POUCH in 1 CASE (0409-7714-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG (0409-7714-13)
MANNITOL 15% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 019603 NDA Hospira, Inc. 0409-7714 0409-7714-03 12 POUCH in 1 CASE (0409-7714-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG (0409-7714-13)

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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Serving leading biopharmaceutical companies globally:

Dow
Federal Trade Commission
Novartis
McKesson
Colorcon
Merck
UBS
Julphar
Teva

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