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PREVPAC (COPACKAGED)

NDA · New Drug Application · Sponsor: TAKEDA PHARMS USA · Approved 1997-12-02

Drug application

FDA Application #
NDA050757
Application type
New Drug Application
Brand name
PREVPAC (COPACKAGED)
Generic name
Amoxicillin
Active ingredients
AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
Dosage form
CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS
Route
ORAL
Marketing status
Discontinued
Sponsor
TAKEDA PHARMS USA
First approval
1997-12-02

Source

Authoritative
Drugs@FDA application overview
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