Source facts
FDA issued an approval letter for SODIUM BICARBONATE on 2026-07-10. The source metadata identifies NDA 220790 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
SODIUM BICARBONATE — FDA Approval Letter (NDA 220790)
Issued to AMNEAL. Application is approved as submitted.
Issued
July 10, 2026Application
NDA 505b1 • 220790
Product
SODIUM BICARBONATE
Company
AMNEAL
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for SODIUM BICARBONATE?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 220790.
- 3Submission: original application.
- 4Sponsor: AMNEAL.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
Read the full FDA approval letter (PDF)
Loading document viewer…
Common questions about the SODIUM BICARBONATE approval letter
Is SODIUM BICARBONATE FDA approved?
This letter documents an FDA approval action: FDA approved NDA 220790 for SODIUM BICARBONATE, sponsored by AMNEAL, on July 10, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 220790?
NDA 220790 is the application under which FDA issued this approval letter for SODIUM BICARBONATE to AMNEAL. The letter is dated July 10, 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.