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Generated: January 22, 2019

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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 seven 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. Twelve suppliers are listed for this compound. Additional details are available on the ethambutol hydrochloride profile page.
Summary for 016320
Tradename:MYAMBUTOL
Applicant:Sti Pharma Llc
Ingredient:ethambutol hydrochloride
Patents:0
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 AUTHORIZED GENERIC A-S Medication Solutions 50090-2399 50090-2399-0 100 TABLET, FILM COATED in 1 BOTTLE (50090-2399-0)

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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