Source facts
FDA issued a tentative approval letter for MILNACIPRAN HYDROCHLORIDE on 2026-06-02. The source metadata identifies ANDA 210944 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordTA · Tentative Approval Letter
MILNACIPRAN HYDROCHLORIDE — FDA Tentative Approval Letter (ANDA 210944)
Issued to MACLEODS PHARMS LTD. Application meets requirements but marketing is blocked (patent/exclusivity).
Issued
June 2, 2026Application
ANDA 505j • 210944
Product
MILNACIPRAN HYDROCHLORIDE
Company
MACLEODS PHARMS LTD
Stage
Final Decision
Assyro regulatory brief
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Key details in this letter
- 1FDA action: tentative approval.
- 2Application: ANDA 210944.
- 3Submission: original application.
- 4Sponsor: MACLEODS PHARMS LTD.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the MILNACIPRAN HYDROCHLORIDE tentative approval letter
Is MILNACIPRAN HYDROCHLORIDE FDA approved?
Not for marketing yet. FDA granted tentative approval to ANDA 210944 for MILNACIPRAN HYDROCHLORIDE on June 2, 2026, meaning the application meets approval standards but patent or exclusivity protections block final approval. The product cannot be marketed until those conditions resolve and FDA issues final approval.
What is ANDA 210944?
ANDA 210944 is the application under which FDA issued this tentative approval letter for MILNACIPRAN HYDROCHLORIDE to MACLEODS PHARMS LTD. The letter is dated June 2, 2026.
What happens after an FDA tentative approval letter?
The product cannot be marketed yet. Tentative approval means the application meets FDA approval standards, but patent or exclusivity protections block final approval. The sponsor typically requests final approval as the blocking date approaches, and FDA re-verifies that the approval conditions still hold before granting it.