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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202743
Company: PADAGIS ISRAEL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/08/2014 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/13/2020 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

11/13/2020 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

AZELASTINE HYDROCHLORIDE

SPRAY, METERED;NASAL; 0.2055MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 202743 PADAGIS ISRAEL
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