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General MedicationsORALGeneric

METHYLPHENIDATE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE

Standard Dose
20MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview METHYLPHENIDATE HYDROCHLORIDE is listed in Drugs@FDA under application 214202 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient METHYLPHENIDATE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 20MG Sponsor TEVA PHARMS USA Submission history Latest submission status date: 2023-02-07 00:00:00.

Structured Monograph

Clinical summary

Approval overview METHYLPHENIDATE HYDROCHLORIDE is listed in Drugs@FDA under application 214202 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient METHYLPHENIDATE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 20MG Sponsor TEVA PHARMS USA Submission history Latest submission status date: 2023-02-07 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.