APPLICATION
ANDA209791
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)
Products
ASPIRIN; OMEPRAZOLENone (Tentative Approval)
ASPIRIN 325MG, OMEPRAZOLE 40MG · TABLET · ORAL
ASPIRIN; OMEPRAZOLENone (Tentative Approval)
ASPIRIN 81MG, OMEPRAZOLE 40MG · TABLET · ORAL
Approval history
2023-01-20UNKNOWN · 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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