General MedicationsORALGeneric

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Standard Dose

1.2GM;120MG

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 - 1.2GM;120MG 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 - 1.2GM;120MG 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.