General MedicationsORALGeneric

FEXOFENADINE HCL; PSEUDOEPHEDRINE HCL

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Standard Dose

60/120MG

Max Dose

Refer to approved labeling

Primary Use

Marketing status: None (Tentative Approval)

Summary

Approval overview FEXOFENADINE HCL; PSEUDOEPHEDRINE HCL is listed in Drugs@FDA under application 076538 (ANDA).

Marketing status: None (Tentative Approval) Active ingredient FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE; ORAL - 60/120MG Sponsor MYLAN Submission history Latest submission status date: 2004-04-30 00:00:00.

Structured Monograph

Clinical summary

Approval overview FEXOFENADINE HCL; PSEUDOEPHEDRINE HCL is listed in Drugs@FDA under application 076538 (ANDA). Marketing status: None (Tentative Approval) Active ingredient FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE; ORAL - 60/120MG Sponsor MYLAN Submission history Latest submission status date: 2004-04-30 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: None (Tentative Approval)

Interaction Notes

No interaction notes stored yet.