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OMEPRAZOLE MAGNESIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD III · Approved 2020-03-25

Drug application

FDA Application #
ANDA211732
Application type
Abbreviated New Drug Application (Generic)
Brand name
OMEPRAZOLE MAGNESIUM
Generic name
OMEPRAZOLE
Active ingredients
OMEPRAZOLE MAGNESIUM
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Marketing status
Over-the-counter
Sponsor
HETERO LABS LTD III
Manufacturer
CHAIN DRUG MARKETING ASSOCIATION, INC.
First approval
2020-03-25

Source

Authoritative
Drugs@FDA application overview
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