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Generated: November 18, 2018

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Details for New Drug Application (NDA): 087409

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NDA 087409 describes MANNITOL 25%, which is a drug marketed by Abraxis Pharm, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Intl Medication, Luitpold, Merck, and Watson Labs, and is included in nine NDAs. It is available from five suppliers. Additional details are available on the MANNITOL 25% profile page.

The generic ingredient in MANNITOL 25% is mannitol. There are eighteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the mannitol profile page.
Summary for 087409
Tradename:MANNITOL 25%
Formulation / Manufacturing:see details
Pharmacology for NDA: 087409
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 087409
Suppliers and Packaging for NDA: 087409
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MANNITOL 25% mannitol INJECTABLE;INJECTION 087409 ANDA American Regent, Inc. 0517-4050 0517-4050-25 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4050-25) > 50 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength12.5GM/50ML
Approval Date:Jan 21, 1982TE:APRLD:No

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