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Serving leading biopharmaceutical companies globally:

US Army
QuintilesIMS
Teva
Merck
Healthtrust
UBS
Fuji
Argus Health
US Department of Justice
Covington

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090410

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NDA 090410 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 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 090410

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090410

Medical Subject Heading (MeSH) Categories for 090410

Suppliers and Packaging for NDA: 090410

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUDESONIDE budesonide CAPSULE;ORAL 090410 ANDA Mylan Pharmaceuticals Inc. 0378-7155 0378-7155-05 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-7155-05)
BUDESONIDE budesonide CAPSULE;ORAL 090410 ANDA Mylan Pharmaceuticals Inc. 0378-7155 0378-7155-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-7155-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength3MG
Approval Date:May 16, 2011TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Medtronic
Cantor Fitzgerald
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Mallinckrodt
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Fish and Richardson
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Moodys
Federal Trade Commission

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