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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 020006


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NDA 020006 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. Nine suppliers are listed for this compound. Additional details are available on the mannitol profile page.
Summary for 020006
Tradename:MANNITOL 5% IN PLASTIC CONTAINER
Applicant:B Braun
Ingredient:mannitol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020006
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 020006
Suppliers and Packaging for NDA: 020006
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MANNITOL 10% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 020006 NDA B. Braun Medical Inc. 0264-7578 0264-7578-10 24 CONTAINER in 1 CASE (0264-7578-10) / 500 mL in 1 CONTAINER
MANNITOL 15% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 020006 NDA B. Braun Medical Inc. 0264-7578 0264-7578-10 24 CONTAINER in 1 CASE (0264-7578-10) / 500 mL in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5GM/100ML
Approval Date:Jul 26, 1993TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10GM/100ML
Approval Date:Jul 26, 1993TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength15GM/100ML
Approval Date:Jul 26, 1993TE:APRLD:No

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