Source facts
FDA issued an approval letter for IPRATROPIUM BROMIDE on 2026-06-02. The source metadata identifies ANDA 217953 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
IPRATROPIUM BROMIDE — FDA Approval Letter (ANDA 217953)
Issued to ARMSTRONG PHARMS. Application is approved as submitted.
Issued
June 2, 2026Application
ANDA 505j • 217953
Product
IPRATROPIUM BROMIDE
Company
ARMSTRONG PHARMS
Stage
Final Decision
Assyro regulatory brief
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Key details in this letter
- 1FDA action: approval.
- 2Application: ANDA 217953.
- 3Submission: original application.
- 4Sponsor: ARMSTRONG PHARMS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the IPRATROPIUM BROMIDE approval letter
Is IPRATROPIUM BROMIDE FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 217953 for IPRATROPIUM BROMIDE, sponsored by ARMSTRONG PHARMS, on June 2, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 217953?
ANDA 217953 is the application under which FDA issued this approval letter for IPRATROPIUM BROMIDE to ARMSTRONG PHARMS. The letter is dated June 2, 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.