Source facts
FDA issued an approval letter for CLEOCIN HYDROCHLORIDE on 2026-03-30. The source metadata identifies NDA 050162 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
CLEOCIN HYDROCHLORIDE — FDA Approval Letter (NDA 050162)
Issued to PFIZER. Application is approved as submitted.
Issued
March 30, 2026Application
NDA 505b1 • 050162
Product
CLEOCIN HYDROCHLORIDE
Company
PFIZER
Stage
Final Decision
Assyro regulatory brief
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 050162.
- 3Submission: supplement.
- 4Sponsor: PFIZER.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the CLEOCIN HYDROCHLORIDE approval letter
Is CLEOCIN HYDROCHLORIDE FDA approved?
This letter documents an FDA approval action: FDA approved NDA 050162 for CLEOCIN HYDROCHLORIDE, sponsored by PFIZER, on March 30, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 050162?
NDA 050162 is the application under which FDA issued this approval letter for CLEOCIN HYDROCHLORIDE to PFIZER. The letter is dated March 30, 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.