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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216421
Company: APOTEX

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZELASTINE HYDROCHLORIDE ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter None No No
AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter None 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
05/29/2024 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216421Orig1s000ltr.pdf

AZELASTINE HYDROCHLORIDE ALLERGY

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SPRAY, METERED;NASAL; 0.2055MG/SPRAY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ASTEPRO ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter Yes 213872 BAYER HLTHCARE
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter No 216576 AMNEAL
AZELASTINE HYDROCHLORIDE ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter No 216421 APOTEX
AZELASTINE HYDROCHLORIDE ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter No 216561 AUROBINDO PHARMA
AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter No 216421 APOTEX
CHILDREN'S ASTEPRO ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter Yes 213872 BAYER HLTHCARE

AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SPRAY, METERED;NASAL; 0.2055MG/SPRAY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ASTEPRO ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter Yes 213872 BAYER HLTHCARE
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter No 216576 AMNEAL
AZELASTINE HYDROCHLORIDE ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter No 216421 APOTEX
AZELASTINE HYDROCHLORIDE ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter No 216561 AUROBINDO PHARMA
AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter No 216421 APOTEX
CHILDREN'S ASTEPRO ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter Yes 213872 BAYER HLTHCARE
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