General MedicationsTRANSDERMALStandard
BUPRENORPHINE
BUPRENORPHINE
Standard Dose
5MCG/HR
Max Dose
Refer to approved labeling
Primary Use
Marketing status: Prescription
Summary
Approval overview BUPRENORPHINE is listed in Drugs@FDA under application 211586 (ANDA).
Marketing status: Prescription Active ingredient BUPRENORPHINE Form and strength FILM, EXTENDED RELEASE;TRANSDERMAL - 5MCG/HR Sponsor AMNEAL Submission history Latest submission status date: 2024-10-31 00:00:00.
Structured Monograph
Clinical summary
Approval overview BUPRENORPHINE is listed in Drugs@FDA under application 211586 (ANDA). Marketing status: Prescription Active ingredient BUPRENORPHINE Form and strength FILM, EXTENDED RELEASE;TRANSDERMAL - 5MCG/HR Sponsor AMNEAL Submission history Latest submission status date: 2024-10-31 00:00:00. Submission type: SUPPL.
Monitoring
- • Review priority: STANDARD
- • Marketing status: Prescription
Interaction Notes
- No interaction notes stored yet.