General MedicationsINJECTIONStandard

ROPIVACAINE HYDROCHLORIDE

Standard Dose

200MG/20ML (10MG/ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview ROPIVACAINE HYDROCHLORIDE is listed in Drugs@FDA under application 219883 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ROPIVACAINE HYDROCHLORIDE Form and strength SOLUTION;INJECTION - 200MG/20ML (10MG/ML) Sponsor ANTHEA PHARMA Submission history Latest submission status date: 2025-03-21 00:00:00.

Structured Monograph

Clinical summary

Approval overview ROPIVACAINE HYDROCHLORIDE is listed in Drugs@FDA under application 219883 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ROPIVACAINE HYDROCHLORIDE Form and strength SOLUTION;INJECTION - 200MG/20ML (10MG/ML) Sponsor ANTHEA PHARMA Submission history Latest submission status date: 2025-03-21 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.