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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 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 NDA: 016320

Sti Pharma Llc
ethambutol hydrochloride
Therapeutic Class:Antimycobacterials

Pharmacology for NDA: 016320

Suppliers and Packaging for NDA: 016320

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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)
ethambutol hydrochloride
TABLET;ORAL 016320 NDA A-S Medication Solutions LLC 54569-3070 54569-3070-2 98 TABLET, FILM COATED in 1 BOTTLE (54569-3070-2)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 002

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

Summary 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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