AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY, AZELASTINE HYDROCHLORIDE ALLERGY
APOTEX · AZELASTINE HYDROCHLORIDE
Open FDA's page for this record- Application number
- ANDA216421
- Sponsor name
- APOTEX
- Submissions
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20240529
- Review priority
- STANDARD
- Submission class code
- UNKNOWN
- Application docs
- ID
- 78841
- Url
- https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216421Orig1s000ltr.pdf
- Date
- 20240620
- Type
- Letter
- Products
- Product number
- 002
- Reference drug
- No
- Brand name
- AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY
- Reference standard
- No
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Marketing status
- Over-the-counter
- Active ingredients
- Name
- AZELASTINE HYDROCHLORIDE
- Strength
- 0.2055MG/SPRAY
- Product number
- 001
- Reference drug
- No
- Brand name
- AZELASTINE HYDROCHLORIDE ALLERGY
- Reference standard
- No
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Marketing status
- Over-the-counter
- Active ingredients
- Name
- AZELASTINE HYDROCHLORIDE
- Strength
- 0.2055MG/SPRAY
- Harmonized identifiers (openFDA)
- Application number
- ANDA216421
- Brand name
- AZELASTINE HYDROCHLORIDE
- Generic name
- AZELASTINE HYDROCHLORIDE
- Manufacturer name
- Allegiant Health, Walgreens
- Product NDC
- 69168-479, 69168-478, 0363-0653
- Product type
- HUMAN OTC DRUG
- Route
- NASAL
- Substance name
- AZELASTINE HYDROCHLORIDE
- RxCUI
- 1797883
- SPL ID
- a38d6984-143a-4e7e-802a-269070c5e13e, fc930f5c-a2b9-4e66-814d-ca8d68cc2d29, 52478468-e6b9-4d34-9822-ee138abdecd8
- SPL set ID
- cc7ddac6-95fa-4bc0-824d-f80e404e8d32, 3e2fdb0d-c2f5-41ab-b1cd-4fae80648112, ec268981-433f-b26b-4ff0-3a121e0a0d08
- Package NDC
- 69168-479-64, 69168-478-63, 69168-478-02, 0363-0653-01, 0363-0653-03, 0363-0653-02, 0363-0653-04, 0363-0653-05
- UNII
- 0L591QR10I