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Last Updated: August 9, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078949

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NDA 078949 describes BUDESONIDE, which is a drug marketed by Alvogen, Amneal Pharms, Appco, Barr Labs Div Teva, Mayne Pharma, Mylan, Sciecure Pharma Inc, Zydus Pharms, Apotex Inc, Cipla, Impax Labs Inc, Lupin Atlantis, Nephron, Sandoz Inc, Teva Pharms, Teva Pharms Usa, and Actavis Labs Fl Inc, and is included in seventeen NDAs. It is available from twenty-eight suppliers. Additional details are available on the BUDESONIDE profile page.

The generic ingredient in BUDESONIDE is budesonide. There are twenty-two drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 078949
Tradename:BUDESONIDE
Applicant:Apotex Inc
Ingredient:budesonide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078949
Medical Subject Heading (MeSH) Categories for 078949
Suppliers and Packaging for NDA: 078949
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUDESONIDE budesonide 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
BUDESONIDE budesonide 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

Profile 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 leading biopharmaceutical companies globally:

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Boehringer Ingelheim
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McKinsey

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