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Serving leading biopharmaceutical companies globally:

Express Scripts
Fish and Richardson
Harvard Business School
US Army

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016320

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NDA 016320 describes MYAMBUTOL, which is a drug marketed by Sti Pharma Llc and is included in one NDA. It is available from nine suppliers. Additional details are available on the MYAMBUTOL profile page.

The generic ingredient in MYAMBUTOL is ethambutol hydrochloride. There are five drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethambutol hydrochloride profile page.
Summary for 016320
Applicant:Sti Pharma Llc
Ingredient:ethambutol hydrochloride
Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 016320
Medical Subject Heading (MeSH) Categories for 016320
Suppliers and Packaging for NDA: 016320
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYAMBUTOL ethambutol hydrochloride TABLET;ORAL 016320 NDA A-S Medication Solutions 50090-0417 50090-0417-2 98 TABLET, FILM COATED in 1 BOTTLE (50090-0417-2)
MYAMBUTOL ethambutol hydrochloride TABLET;ORAL 016320 NDA State of Florida DOH Central Pharmacy 53808-0977 53808-0977-1 30 TABLET in 1 BLISTER PACK (53808-0977-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength200MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Cantor Fitzgerald

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