Source facts
FDA issued an approval letter for PARLODEL on 2026-07-02. The source metadata identifies NDA 017962 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
PARLODEL — FDA Approval Letter (NDA 017962)
Issued to ESJAY PHARMA. Application is approved as submitted.
Issued
July 2, 2026Application
NDA 505b1 • 017962
Product
PARLODEL
Company
ESJAY PHARMA
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for PARLODEL?
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 017962.
- 3Submission: supplement.
- 4Sponsor: ESJAY PHARMA.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the PARLODEL approval letter
Is PARLODEL FDA approved?
This letter documents an FDA approval action: FDA approved NDA 017962 for PARLODEL, sponsored by ESJAY PHARMA, on July 2, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 017962?
NDA 017962 is the application under which FDA issued this approval letter for PARLODEL to ESJAY PHARMA. The letter is dated July 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.