Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 13, 2019

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 one supplier. 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 seventy-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate profile page.
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 Salix Pharmaceuticals, Inc. 65649-701 65649-701-41 100 TABLET in 1 BOTTLE, PLASTIC (65649-701-41)
Paragraph IV (Patent) Challenges for 021892
Tradename Dosage Ingredient NDA Submissiondate
OSMOPREP TABLET;ORAL sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate 021892 2008-04-09

Profile for product number 001

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

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