Source facts
FDA issued an approval letter for ALTACE on 2026-05-11. The source metadata identifies NDA 019901 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ALTACE — FDA Approval Letter (NDA 019901)
Issued to KING PHARMS LLC. Application is approved as submitted.
Issued
May 11, 2026Application
NDA 505b1 • 019901
Product
ALTACE
Company
KING PHARMS LLC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for ALTACE?
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 019901.
- 3Submission: supplement.
- 4Sponsor: KING PHARMS LLC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ALTACE approval letter
Is ALTACE FDA approved?
This letter documents an FDA approval action: FDA approved NDA 019901 for ALTACE, sponsored by KING PHARMS LLC, on May 11, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 019901?
NDA 019901 is the application under which FDA issued this approval letter for ALTACE to KING PHARMS LLC. The letter is dated May 11, 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.