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Serving leading biopharmaceutical companies globally:

Covington
Fish and Richardson
Dow
Chubb
Argus Health
Cipla
Fuji
Accenture
Deloitte
AstraZeneca

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201966

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NDA 201966 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 201966
Pharmacology for NDA: 201966
Medical Subject Heading (MeSH) Categories for 201966
Suppliers and Packaging for NDA: 201966
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUDESONIDE budesonide SUSPENSION;INHALATION 201966 ANDA Sandoz Inc 0781-7515 0781-7515-87 6 POUCH in 1 CARTON (0781-7515-87) > 5 AMPULE in 1 POUCH (0781-7515-14) > 2 mL in 1 AMPULE
BUDESONIDE budesonide SUSPENSION;INHALATION 201966 ANDA Sandoz Inc 0781-7516 0781-7516-87 6 POUCH in 1 CARTON (0781-7516-87) > 5 AMPULE in 1 POUCH (0781-7516-14) > 2 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength1MG/2ML
Approval Date:Sep 27, 2013TE:ANRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength0.5MG/2ML
Approval Date:Sep 27, 2013TE:ANRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength0.25MG/2ML
Approval Date:Sep 27, 2013TE:ANRLD:No

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Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Fish and Richardson
Cipla
Covington
Daiichi Sankyo
Healthtrust
Johnson and Johnson
McKesson

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