Budesonide
Summary of product characteristics
Effective Time
20220727
Version
6
Spl Product Data Elements
budesonide budesonide BUDESONIDE BUDESONIDE ACETYLTRIBUTYL CITRATE ALCOHOL AMMONIA BUTYL ALCOHOL DIMETHICONE ETHYLCELLULOSES FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYSORBATE 80 POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER OPAQUE LIGHT-ORANGE OPAQUE WHITE CAPSULE 720
Application Number
ANDA206134
Brand Name
Budesonide
Generic Name
budesonide
Product Ndc
70771-1075
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1075-1 in bottle of 100 capsules Budesonide Delayed-Release Capsules (Enteric Coated) 3 mg 100 capsules Rx only Budesonide Capsules label
100 mins
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