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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Daiichi Sankyo
US Army
Harvard Business School

Generated: September 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204548

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NDA 204548 describes BUDESONIDE, which is a drug marketed by Amneal Pharms, Apotex Inc, Impax Labs Inc, Mylan, Teva Pharms, Mayne Pharma, Alvogen Malta, Zydus Pharms Usa Inc, Teva Pharms Usa, Sandoz Inc, Appco Pharma Llc, and Barr Labs Div Teva, and is included in thirteen NDAs. It is available from twenty-nine suppliers. Additional details are available on the BUDESONIDE profile page.

The generic ingredient in BUDESONIDE is budesonide. There are twenty drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Summary for NDA: 204548

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204548

Suppliers and Packaging for NDA: 204548

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUSPENSION;INHALATION 204548 ANDA Teva Pharmaceuticals USA, Inc. 0093-6817 0093-6817-73 6 POUCH in 1 CARTON (0093-6817-73) > 5 AMPULE in 1 POUCH (0093-6817-45) > 2 mL in 1 AMPULE (0093-6817-19)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength1MG/2ML
Approval Date:Mar 8, 2016TE:ANRLD:No

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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Federal Trade Commission
US Department of Justice
Johnson and Johnson
Boehringer Ingelheim
US Army

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