BioPharmaceutical Business Intelligence

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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Cantor Fitzgerald
Boehringer Ingelheim
US Army
Farmers Insurance

Generated: September 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078949

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NDA 078949 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 thirty 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-eight suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Summary for NDA: 078949

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

Pharmacology for NDA: 078949

Suppliers and Packaging for NDA: 078949

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPRAY, METERED;NASAL 078949 ANDA Walgreens 0363-0048 0363-0048-01 1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (0363-0048-01) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY
SPRAY, METERED;NASAL 078949 ANDA Rugby Laboratories 0536-1112 0536-1112-40 1 BOTTLE, SPRAY in 1 CARTON (0536-1112-40) > 60 SPRAY, METERED in 1 BOTTLE, SPRAY

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SPRAY, METERED;NASALStrength0.032MG/SPRAY
Approval Date:Nov 20, 2015TE:RLD:No

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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Farmers Insurance
US Department of Justice
Express Scripts
Daiichi Sankyo

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