General MedicationsORALStandard

METHYLPHENIDATE HYDROCHLORIDE

Standard Dose

5MG/ML

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview METHYLPHENIDATE HYDROCHLORIDE is listed in Drugs@FDA under application 206049 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient METHYLPHENIDATE HYDROCHLORIDE Form and strength FOR SUSPENSION, EXTENDED RELEASE;ORAL - 5MG/ML Sponsor ACTAVIS LABS FL INC Submission history Latest submission status date: 2018-05-17 00:00:00.

Structured Monograph

Clinical summary

Approval overview METHYLPHENIDATE HYDROCHLORIDE is listed in Drugs@FDA under application 206049 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient METHYLPHENIDATE HYDROCHLORIDE Form and strength FOR SUSPENSION, EXTENDED RELEASE;ORAL - 5MG/ML Sponsor ACTAVIS LABS FL INC Submission history Latest submission status date: 2018-05-17 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.