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Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021892

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NDA 021892 describes OSMOPREP, which is a drug marketed by Salix Pharms and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the OSMOPREP profile page.

The generic ingredient in OSMOPREP is sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate. There are one thousand four hundred and twenty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate profile page.
Summary for 021892
Tradename:OSMOPREP
Applicant:Salix Pharms
Ingredient:sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
Patents:1
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021892
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OSMOPREP sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate TABLET;ORAL 021892 NDA Physicians Total Care, Inc. 54868-5889 E 54868-5889-0
OSMOPREP sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate TABLET;ORAL 021892 NDA Physicians Total Care, Inc. 54868-5889 E 54868-5889-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.398GM;1.102GM
Approval Date:Mar 16, 2006TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jun 22, 2028Product Flag?YSubstance Flag?YDelist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
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Cantor Fitzgerald
Boehringer Ingelheim
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