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Generated: March 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077519

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NDA 077519 describes BUDESONIDE, which is a drug marketed by Alvogen Malta, Amneal Pharms, Appco Pharma Llc, Barr Labs Div Teva, Mayne Pharma, Mylan, Sciecure Pharma Inc, Zydus Pharms Usa Inc, Apotex Inc, Cipla Ltd, Impax Labs Inc, Sandoz Inc, Teva Pharms, and Teva Pharms Usa, and is included in fifteen NDAs. It is available from thirty-one suppliers. Additional details are available on the BUDESONIDE profile page.

The generic ingredient in BUDESONIDE is budesonide. There are twenty-one drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 077519
Pharmacology for NDA: 077519
Medical Subject Heading (MeSH) Categories for 077519
Suppliers and Packaging for NDA: 077519
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUDESONIDE budesonide SUSPENSION;INHALATION 077519 ANDA Teva Pharmaceuticals USA, Inc. 0093-6815 N 0093-6815-73
BUDESONIDE budesonide SUSPENSION;INHALATION 077519 ANDA Teva Pharmaceuticals USA, Inc. 0093-6815 N 0093-6815-76

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength0.25MG/2ML
Approval Date:Nov 18, 2008TE:ANRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength0.5MG/2ML
Approval Date:Nov 18, 2008TE:ANRLD:No

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