General MedicationsORALGeneric

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Standard Dose

5MG;120MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE is listed in Drugs@FDA under application 212409 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 5MG;120MG Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2023-03-08 00:00:00.

Structured Monograph

Clinical summary

Approval overview CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE is listed in Drugs@FDA under application 212409 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 5MG;120MG Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2023-03-08 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.