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ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: FRESENIUS KABI USA · Approved 2013-07-19

Drug application

FDA Application #
ANDA202253
Application type
Abbreviated New Drug Application (Generic)
Brand name
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Generic name
ONDANSETRON HYDROCHLORIDE
Active ingredients
ONDANSETRON HYDROCHLORIDE
Dosage form
INJECTABLE
Route
INJECTION
Marketing status
Prescription
Sponsor
FRESENIUS KABI USA
Manufacturer
Fresenius Kabi USA, LLC
First approval
2013-07-19

Source

Authoritative
Drugs@FDA application overview
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