Source facts
FDA issued an approval letter for DESOGESTREL AND ETHINYL ESTRADIOL on 2026-03-23. The source metadata identifies ANDA 219761 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
DESOGESTREL AND ETHINYL ESTRADIOL — FDA Approval Letter (ANDA 219761)
Issued to ANNORA PHARMA. Application is approved as submitted.
Issued
March 23, 2026Application
ANDA 505j • 219761
Product
DESOGESTREL AND ETHINYL ESTRADIOL
Company
ANNORA PHARMA
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for DESOGESTREL AND ETHINYL ESTRADIOL?
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: ANDA 219761.
- 3Submission: original application.
- 4Sponsor: ANNORA PHARMA.
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 DESOGESTREL AND ETHINYL ESTRADIOL approval letter
Is DESOGESTREL AND ETHINYL ESTRADIOL FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 219761 for DESOGESTREL AND ETHINYL ESTRADIOL, sponsored by ANNORA PHARMA, on March 23, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 219761?
ANDA 219761 is the application under which FDA issued this approval letter for DESOGESTREL AND ETHINYL ESTRADIOL to ANNORA PHARMA. The letter is dated March 23, 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.