General MedicationsORALGeneric

ONDANSETRON HYDROCHLORIDE

Standard Dose

16MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: None (Tentative Approval)

Summary

Approval overview ONDANSETRON HYDROCHLORIDE is listed in Drugs@FDA under application 077303 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient ONDANSETRON HYDROCHLORIDE Form and strength TABLET; ORAL - 16MG Sponsor CHARTWELL MOLECULES Submission history Latest submission status date: 2018-02-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview ONDANSETRON HYDROCHLORIDE is listed in Drugs@FDA under application 077303 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient ONDANSETRON HYDROCHLORIDE Form and strength TABLET; ORAL - 16MG Sponsor CHARTWELL MOLECULES Submission history Latest submission status date: 2018-02-26 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: None (Tentative Approval)
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.