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General MedicationsORALGeneric

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE

CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

Standard Dose
4MG/5ML;5MG/5ML;60MG/5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE is listed in Drugs@FDA under application 206660 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE Form and strength SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML Sponsor SCIEGEN PHARMS Submission history Latest submission status date: 2023-12-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE is listed in Drugs@FDA under application 206660 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE Form and strength SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML Sponsor SCIEGEN PHARMS Submission history Latest submission status date: 2023-12-15 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.