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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213872
Company: BAYER HLTHCARE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ASTEPRO ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter None Yes Yes
CHILDREN'S ASTEPRO ALLERGY AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/17/2021 ORIG-1 Approval Type 8 - Partial Rx to OTC Switch STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213872Orig1s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213872Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/213872Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/20/2023 SUPPL-4 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213872Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213872Orig1s004ltr.pdf
11/01/2021 SUPPL-1 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213872Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/20/2023 SUPPL-4 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213872Orig1s004lbl.pdf
06/17/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213872Orig1s000Lbl.pdf

ASTEPRO 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

CHILDREN'S ASTEPRO 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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