Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078939
Company: LUPIN

Products on ANDA 078939

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ETHAMBUTOL HYDROCHLORIDE	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	AB	No	No
ETHAMBUTOL HYDROCHLORIDE	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078939

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/17/2009	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 078939

ETHAMBUTOL HYDROCHLORIDE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ETHAMBUTOL HYDROCHLORIDE	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	075095	EPIC PHARMA LLC
ETHAMBUTOL HYDROCHLORIDE	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	078939	LUPIN
MYAMBUTOL	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	Yes	AB	016320	STI PHARMA LLC

TABLET;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ETHAMBUTOL HYDROCHLORIDE	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET;ORAL	Prescription	No	AB	075095	EPIC PHARMA LLC
ETHAMBUTOL HYDROCHLORIDE	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET;ORAL	Prescription	No	AB	078939	LUPIN
MYAMBUTOL	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET;ORAL	Prescription	Yes	AB	016320	STI PHARMA LLC