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Serving 500+ biopharmaceutical companies globally:

Express Scripts
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Harvard Business School
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Generated: July 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022442

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NDA 022442 describes REZIRA, which is a drug marketed by Cypress Pharm and is included in one NDA. It is available from one supplier. Additional details are available on the REZIRA profile page.

The generic ingredient in REZIRA is hydrocodone bitartrate; pseudoephedrine hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the hydrocodone bitartrate; pseudoephedrine hydrochloride profile page.

Summary for NDA: 022442

Formulation / Manufacturing:see details

Pharmacology for NDA: 022442

Suppliers and Packaging for NDA: 022442

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
hydrocodone bitartrate; pseudoephedrine hydrochloride
SOLUTION;ORAL 022442 NDA Hawthorn Pharmaceuticals, Inc. 63717-875 63717-875-16 480 mL in 1 BOTTLE (63717-875-16)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/5ML;60MG/5ML
Approval Date:Jun 8, 2011TE:AARLD:Yes

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Serving 500+ biopharmaceutical companies globally:

Argus Health
US Department of Justice
Boehringer Ingelheim
Cantor Fitzgerald

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