General MedicationsTRANSDERMALStandard
METHYLPHENIDATE
METHYLPHENIDATE
Standard Dose
10MG/9HR (1.1MG/HR)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview METHYLPHENIDATE is listed in Drugs@FDA under application 206497 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient METHYLPHENIDATE Form and strength FILM, EXTENDED RELEASE;TRANSDERMAL - 10MG/9HR (1.1MG/HR) Sponsor MYLAN TECH VIATRIS Submission history Latest submission status date: 2024-08-30 00:00:00.
Structured Monograph
Clinical summary
Approval overview METHYLPHENIDATE is listed in Drugs@FDA under application 206497 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient METHYLPHENIDATE Form and strength FILM, EXTENDED RELEASE;TRANSDERMAL - 10MG/9HR (1.1MG/HR) Sponsor MYLAN TECH VIATRIS Submission history Latest submission status date: 2024-08-30 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.