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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 205457


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NDA 205457 describes BUDESONIDE, which is a drug marketed by Padagis Israel, Amneal Pharms, Aurobindo Pharma Usa, Barr Labs Div Teva, Dr Reddys Labs Sa, Natco, Rising, Sciecure Pharma Inc, Zydus Pharms, Apotex Inc, Cipla, Eugia Pharma, Impax Labs Inc, Lupin, Nephron, Sandoz, Sun Pharm, Teva Pharms, Teva Pharms Usa, Actavis Labs Fl Inc, and Mylan, and is included in twenty-one NDAs. It is available from thirty-five suppliers. Additional details are available on the BUDESONIDE profile page.

The generic ingredient in BUDESONIDE is budesonide. There are twenty-two drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 205457
Tradename:BUDESONIDE
Applicant:Actavis Labs Fl Inc
Ingredient:budesonide
Patents:0
Pharmacology for NDA: 205457
Medical Subject Heading (MeSH) Categories for 205457
Suppliers and Packaging for NDA: 205457
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUDESONIDE budesonide TABLET, EXTENDED RELEASE;ORAL 205457 ANDA Actavis Pharma, Inc. 0591-2510 0591-2510-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-2510-30)
BUDESONIDE budesonide TABLET, EXTENDED RELEASE;ORAL 205457 ANDA Golden State Medical Supply, Inc. 51407-824 51407-824-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (51407-824-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength9MG
Approval Date:Jul 3, 2018TE:ABRLD:No

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