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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. Two suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate; pseudoephedrine hydrochloride profile page.

Summary for NDA: 022442

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)
hydrocodone bitartrate; pseudoephedrine hydrochloride
SOLUTION;ORAL 022442 NDA Hawthorn Pharmaceuticals, Inc. 63717-875 63717-875-99 12 BOTTLE in 1 CARTON (63717-875-99) > 5 mL in 1 BOTTLE

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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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.