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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 080677

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NDA 080677 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 four 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 080677
Tradename:MANNITOL 25%
Applicant:Fresenius Kabi Usa
Formulation / Manufacturing:see details
Pharmacology for NDA: 080677
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 080677
Suppliers and Packaging for NDA: 080677
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MANNITOL 25% mannitol INJECTABLE;INJECTION 080677 ANDA Fresenius Kabi USA, LLC 63323-024 63323-024-25 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-024-25) > 50 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength12.5GM/50ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts

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