APPLICATION
ANDA075791
TYPE
ANDA
ORIGINAL APPROVAL
2002-12-23
LATEST ACTION
2002-12-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
None (Tentative Approval)
Products
OMEPRAZOLENone (Tentative Approval)
OMEPRAZOLE 20MG · CAPSULE, DELAYED REL PELLETS · ORAL
OMEPRAZOLENone (Tentative Approval)
OMEPRAZOLE 10MG · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2002-12-23OriginalAP
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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