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Generated: August 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207367

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NDA 207367 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, Teva Pharms Usa, and Actavis Labs Fl Inc, and is included in sixteen 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-one drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 207367
Tradename:BUDESONIDE
Applicant:Appco Pharma Llc
Ingredient:budesonide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207367
Medical Subject Heading (MeSH) Categories for 207367
Suppliers and Packaging for NDA: 207367
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUDESONIDE budesonide CAPSULE;ORAL 207367 ANDA APPCO PHARMA LLC 55801-520 N 55801-520-01
BUDESONIDE budesonide CAPSULE;ORAL 207367 ANDA APPCO PHARMA LLC 55801-520 N 55801-520-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength3MG
Approval Date:Apr 7, 2017TE:ABRLD:No

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