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General MedicationsORALGeneric

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Standard Dose
600MG;60MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE is listed in Drugs@FDA under application 216082 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 600MG;60MG Sponsor GRANULES Submission history Latest submission status date: 2022-08-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE is listed in Drugs@FDA under application 216082 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 600MG;60MG Sponsor GRANULES Submission history Latest submission status date: 2022-08-22 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.