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OMEPRAZOLE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SANDOZ · Approved 2002-12-23

Drug application

FDA Application #
ANDA075791
Application type
Abbreviated New Drug Application (Generic)
Brand name
OMEPRAZOLE
Generic name
Omeprazole
Active ingredients
OMEPRAZOLE
Dosage form
CAPSULE, DELAYED REL PELLETS
Route
ORAL
Marketing status
None (Tentative Approval)
Sponsor
SANDOZ
First approval
2002-12-23

Source

Authoritative
Drugs@FDA application overview
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