Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201846
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.1876MG BASE/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
08/31/2012 ORIG-1 Approval Not Applicable Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/201846Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/05/2017 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

01/05/2017 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

AZELASTINE HYDROCHLORIDE

SPRAY, METERED;NASAL; EQ 0.1876MG BASE/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ASTEPRO AZELASTINE HYDROCHLORIDE EQ 0.1876MG BASE/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 022203 MYLAN SPECIALITY LP
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.1876MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 201846 APOTEX INC
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.1876MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 202743 PERRIGO ISRAEL
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.1876MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 207243 WEST-WARD PHARMS INT

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