Issued to APOTEX. Application is approved as submitted.
Issued
June 9, 2026Application
ANDA 505j • 210456
Product
MULTIPLE VITAMINS INJECTION PEDIATRIC (PHARMACY BULK PACKAGE)
Company
APOTEX
Stage
Final Decision
Assyro regulatory brief
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FDA issued an approval letter for MULTIPLE VITAMINS INJECTION PEDIATRIC (PHARMACY BULK PACKAGE) on 2026-06-09. The source metadata identifies ANDA 210456 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
This letter documents an FDA approval action: FDA approved ANDA 210456 for MULTIPLE VITAMINS INJECTION PEDIATRIC (PHARMACY BULK PACKAGE), sponsored by APOTEX, on June 9, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
ANDA 210456 is the application under which FDA issued this approval letter for MULTIPLE VITAMINS INJECTION PEDIATRIC (PHARMACY BULK PACKAGE) to APOTEX. The letter is dated June 9, 2026.
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.