General MedicationsORALGeneric
OBREDON
GUAIFENESIN; HYDROCODONE BITARTRATE
Standard Dose
200MG/5ML;2.5MG/5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary
Approval overview OBREDON is listed in Drugs@FDA under application 205474 (NDA).
Review priority: STANDARD Marketing status: Discontinued Active ingredient GUAIFENESIN; HYDROCODONE BITARTRATE Form and strength SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML Sponsor SOVEREIGN PHARMS Submission history Latest submission status date: 2025-12-22 00:00:00.
Structured Monograph
Clinical summary
Approval overview OBREDON is listed in Drugs@FDA under application 205474 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient GUAIFENESIN; HYDROCODONE BITARTRATE Form and strength SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML Sponsor SOVEREIGN PHARMS Submission history Latest submission status date: 2025-12-22 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Discontinued
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.