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10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Key Takeaways

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strength TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor LANNETT CO INC Submission history Latest submission status date: 2025-10-02 00:00:00.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strength TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor LANNETT CO INC Submission history Latest submission status date: 2025-10-02 00:00:00.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