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Details for New Drug Application (NDA): 016772

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NDA 016772 describes RESECTISOL IN PLASTIC CONTAINER, which is a drug marketed by B Braun and is included in one NDA. It is available from one supplier. Additional details are available on the RESECTISOL IN PLASTIC CONTAINER profile page.

The generic ingredient in RESECTISOL 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 NDA: 016772

Tradename:
RESECTISOL IN PLASTIC CONTAINER
Applicant:
B Braun
Ingredient:
mannitol
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 016772

Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 016772

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RESECTISOL IN PLASTIC CONTAINER
mannitol
SOLUTION;IRRIGATION 016772 NDA B. Braun Medical Inc. 0264-2303 0264-2303-50 8 CONTAINER in 1 CASE (0264-2303-50) > 2000 mL in 1 CONTAINER
RESECTISOL IN PLASTIC CONTAINER
mannitol
SOLUTION;IRRIGATION 016772 NDA B. Braun Medical Inc. 0264-2303 0264-2303-70 4 CONTAINER in 1 CASE (0264-2303-70) > 4000 mL in 1 CONTAINER

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IRRIGATIONStrength5GM/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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