General MedicationsORALStandard

MINOCYCLINE HYDROCHLORIDE

Standard Dose

EQ 115MG BASE

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview MINOCYCLINE HYDROCHLORIDE is listed in Drugs@FDA under application 204453 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient MINOCYCLINE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 115MG BASE Sponsor ALKEM LABS LTD Submission history Latest submission status date: 2025-03-31 00:00:00.

Structured Monograph

Clinical summary

Approval overview MINOCYCLINE HYDROCHLORIDE is listed in Drugs@FDA under application 204453 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient MINOCYCLINE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 115MG BASE Sponsor ALKEM LABS LTD Submission history Latest submission status date: 2025-03-31 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.