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Generated: May 23, 2017

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Details for New Drug Application (NDA): 076057

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NDA 076057 describes ETHAMBUTOL HYDROCHLORIDE, which is a drug marketed by Lupin, Barr, and Akorn, and is included in three NDAs. It is available from six suppliers. Additional details are available on the ETHAMBUTOL HYDROCHLORIDE profile page.

The generic ingredient in ETHAMBUTOL HYDROCHLORIDE is ethambutol hydrochloride. There are five drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ethambutol hydrochloride profile page.

Summary for NDA: 076057

Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 076057

Suppliers and Packaging for NDA: 076057

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ethambutol hydrochloride
TABLET;ORAL 076057 ANDA Barr Laboratories Inc. 0555-0923 0555-0923-02 100 TABLET, FILM COATED in 1 BOTTLE (0555-0923-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Nov 26, 2001TE:ABRLD:No

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