Budesonide (enteric coated)

Product NDC

47781-146

11-digit product format

477810146

Labeler code

47781

Product ID

47781-146_e13a50cc-0126-ffb3-9cc4-cd0d8cf1fcc3

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Budesonide

Dosage form

CAPSULE

Route

ORAL

Labeler

Alvogen, Inc.

Application

ANDA206724

Marketing category

ANDA

Marketing start

2016-11-23

Marketing end

2019-08-31

Substance

BUDESONIDE

Active strength

3 mg/1

Pharmacologic classes

Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record