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Details for New Drug Application (NDA): 078949

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NDA 078949 describes BUDESONIDE, which is a drug marketed by Apotex Inc, Impax Labs Inc, Mylan, Teva Pharms, Mayne Pharma, Alvogen Malta, Teva Pharms Usa, Sandoz Inc, and Barr Labs Div Teva, and is included in ten NDAs. It is available from twenty-six suppliers. Additional details are available on the BUDESONIDE profile page.

The generic ingredient in BUDESONIDE is budesonide. There are nineteen 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 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.