General MedicationsNASALStandard

AZELASTINE HYDROCHLORIDE

Standard Dose

0.137MG/SPRAY

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview AZELASTINE HYDROCHLORIDE is listed in Drugs@FDA under application 212289 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AZELASTINE HYDROCHLORIDE Form and strength SPRAY, METERED;NASAL - 0.137MG/SPRAY Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2020-05-08 00:00:00.

Structured Monograph

Clinical summary

Approval overview AZELASTINE HYDROCHLORIDE is listed in Drugs@FDA under application 212289 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AZELASTINE HYDROCHLORIDE Form and strength SPRAY, METERED;NASAL - 0.137MG/SPRAY Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2020-05-08 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.