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BUDESONIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PADAGIS ISRAEL · Approved 2023-04-12

Drug application

FDA Application #
ANDA215328
Application type
Abbreviated New Drug Application (Generic)
Brand name
BUDESONIDE
Generic name
BUDESONIDE
Active ingredients
BUDESONIDE
Dosage form
AEROSOL, FOAM
Route
RECTAL
Marketing status
Prescription
Sponsor
PADAGIS ISRAEL
Manufacturer
Padagis Israel Pharmaceuticals Ltd
First approval
2023-04-12

Source

Authoritative
Drugs@FDA application overview
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