Source facts
FDA issued an approval letter for MULTIPLE VITAMINS INJECTION ADULT on 2026-05-26. The source metadata identifies ANDA 210672 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
MULTIPLE VITAMINS INJECTION ADULT — FDA Approval Letter (ANDA 210672)
Issued to APOTEX. Application is approved as submitted.
Issued
May 26, 2026Application
ANDA 505j • 210672
Product
MULTIPLE VITAMINS INJECTION ADULT
Company
APOTEX
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for MULTIPLE VITAMINS INJECTION ADULT?
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Key details in this letter
- 1FDA action: approval.
- 2Application: ANDA 210672.
- 3Submission: original application.
- 4Sponsor: APOTEX.
Suggested next step
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Common questions about the MULTIPLE VITAMINS INJECTION ADULT approval letter
Is MULTIPLE VITAMINS INJECTION ADULT FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 210672 for MULTIPLE VITAMINS INJECTION ADULT, sponsored by APOTEX, on May 26, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 210672?
ANDA 210672 is the application under which FDA issued this approval letter for MULTIPLE VITAMINS INJECTION ADULT to APOTEX. The letter is dated May 26, 2026.
What happens after an FDA approval letter?
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.