General MedicationsORALStandard

HYDROCODONE BITARTRATE

Standard Dose

100MG

Max Dose

Refer to approved labeling

Primary Use

Marketing status: Prescription

Summary

Approval overview HYDROCODONE BITARTRATE is listed in Drugs@FDA under application 208269 (ANDA).

Marketing status: Prescription Active ingredient HYDROCODONE BITARTRATE Form and strength TABLET, EXTENDED RELEASE;ORAL - 100MG Sponsor ALVOGEN Submission history Latest submission status date: 2024-10-31 00:00:00.

Structured Monograph

Clinical summary

Approval overview HYDROCODONE BITARTRATE is listed in Drugs@FDA under application 208269 (ANDA). Marketing status: Prescription Active ingredient HYDROCODONE BITARTRATE Form and strength TABLET, EXTENDED RELEASE;ORAL - 100MG Sponsor ALVOGEN 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.