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Details for New Drug Application (NDA): 075095

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NDA 075095 describes ETHAMBUTOL HYDROCHLORIDE, which is a drug marketed by Lupin, Barr, and Versapharm Inc, and is included in three NDAs. It is available from seven 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. Fourteen suppliers are listed for this compound. Additional details are available on the ethambutol hydrochloride profile page.

Summary for NDA: 075095

Versapharm Inc
ethambutol hydrochloride
Therapeutic Class:Antimycobacterials

Pharmacology for NDA: 075095

Suppliers and Packaging for NDA: 075095

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ethambutol hydrochloride
TABLET;ORAL 075095 ANDA REMEDYREPACK INC. 49349-446 49349-446-02 30 TABLET in 1 BLISTER PACK (49349-446-02)
ethambutol hydrochloride
TABLET;ORAL 075095 ANDA Physicians Total Care, Inc. 54868-6219 54868-6219-0 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-6219-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Nov 30, 1999TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Nov 30, 1999TE:ABRLD:No

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