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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 Luitpold, Merck, Igi Labs Inc, Intl Medication, Abraxis Pharm, Watson Labs, Hospira, and Fresenius Kabi Usa, 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 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: 087409

Tradename:
MANNITOL 25%
Applicant:
Luitpold
Ingredient:
mannitol
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 087409

Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis

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

Summary for product number 001

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


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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