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Details for New Drug Application (NDA): 018316

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NDA 018316 describes SORBITOL-MANNITOL IN PLASTIC CONTAINER, which is a drug marketed by Hospira and is included in two NDAs. It is available from one supplier. Additional details are available on the SORBITOL-MANNITOL IN PLASTIC CONTAINER profile page.

The generic ingredient in SORBITOL-MANNITOL IN PLASTIC CONTAINER is mannitol; sorbitol. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the mannitol; sorbitol profile page.

Summary for NDA: 018316

mannitol; sorbitol
Formulation / Manufacturing:see details

Pharmacology for NDA: 018316

Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 018316

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
mannitol; sorbitol
SOLUTION;IRRIGATION 018316 NDA Hospira, Inc. 0409-7981 0409-7981-08 4 BAG in 1 CASE (0409-7981-08) > 3000 mL in 1 BAG

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IRRIGATIONStrength540MG/100ML;2.7GM/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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