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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Fuji
Cipla
Cerilliant
US Army
Dow
Merck
Express Scripts
Chubb
UBS

Generated: January 22, 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, 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-one 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 207367
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 55801-520-02 500 CAPSULE in 1 BOTTLE (55801-520-02)
BUDESONIDE budesonide CAPSULE;ORAL 207367 ANDA APPCO PHARMA LLC 55801-520 55801-520-01 100 CAPSULE in 1 BOTTLE (55801-520-01)

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Colorcon
Cipla
Merck
Dow
Deloitte
Covington
Moodys
McKinsey
Johnson and Johnson

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