General MedicationsORALGeneric

METADATE ER

METHYLPHENIDATE HYDROCHLORIDE

Standard Dose

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview METADATE ER is listed in Drugs@FDA under application 040306 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient METHYLPHENIDATE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor LANNETT CO INC Submission history Latest submission status date: 2025-10-02 00:00:00.

Structured Monograph

Clinical summary

Approval overview METADATE ER is listed in Drugs@FDA under application 040306 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient METHYLPHENIDATE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor LANNETT CO INC Submission history Latest submission status date: 2025-10-02 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.