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General MedicationsORALGeneric

COTEMPLA XR-ODT

METHYLPHENIDATE

Standard Dose
34.6MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview COTEMPLA XR-ODT is listed in Drugs@FDA under application 205489 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient METHYLPHENIDATE Form and strength TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - 34.6MG Sponsor NEOS THERAPS INC Submission history Latest submission status date: 2025-09-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview COTEMPLA XR-ODT is listed in Drugs@FDA under application 205489 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient METHYLPHENIDATE Form and strength TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - 34.6MG Sponsor NEOS THERAPS INC Submission history Latest submission status date: 2025-09-23 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
COTEMPLA XR-ODT (METHYLPHENIDATE) | Drug Monograph | MedicHelpline