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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202853
Company: PADAGIS ISRAEL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE 0.665MG/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
01/31/2017 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
11/16/2021 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

OLOPATADINE HYDROCHLORIDE

SPRAY, METERED;NASAL; 0.665MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 210901 AMNEAL
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 091572 APOTEX INC
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 202853 PADAGIS ISRAEL
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