APPLICATION
ANDA220314
TYPE
ANDA
ROUTE
SOLUTION
DOSAGE FORM
INJECTION
MARKETING STATUS
None (Tentative Approval)
Products
SEMAGLUTIDENone (Tentative Approval)
SEMAGLUTIDE 8MG/3ML · INJECTION · SOLUTION
SEMAGLUTIDENone (Tentative Approval)
SEMAGLUTIDE 2MG/3ML · INJECTION · SOLUTION
SEMAGLUTIDENone (Tentative Approval)
SEMAGLUTIDE 4MG/3ML · INJECTION · SOLUTION
Approval history
2026-04-07UNKNOWN · Original · standardTA
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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