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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205474

OBREDON (GUAIFENESIN; HYDROCODONE BITARTRATE)
200MG/5ML;2.5MG/5ML
Marketing Status: Discontinued
Active Ingredient: GUAIFENESIN; HYDROCODONE BITARTRATE
Proprietary Name: OBREDON
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 200MG/5ML;2.5MG/5ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205474
Product Number: 001
Approval Date: Nov 14, 2014
Applicant Holder Full Name: SOVEREIGN PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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