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Last Updated: March 19, 2026

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 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. Nine 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
Ingredient:	mannitol
Patents:	0

Pharmacology for NDA: 080677

Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Diuresis

Medical Subject Heading (MeSH) Categories for 080677

Diuretics, Osmotic
Sweetening Agents

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 (63323-024-01)
MANNITOL 25%	mannitol	INJECTABLE;INJECTION	080677	ANDA	ProPharma Distribution	84549-024	84549-024-25	50 mL in 1 VIAL, SINGLE-DOSE (84549-024-25)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	12.5GM/50ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	No

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