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FDA Drug information

Budesonide

Read time: 1 mins
Marketing start date: 27 Apr 2024
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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

Drug section

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Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

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