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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022442

REZIRA (HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE)
5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Proprietary Name: REZIRA
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022442
Product Number: 001
Approval Date: Jun 8, 2011
Applicant Holder Full Name: PERSION PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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