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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075095
Company: EPIC PHARMA LLC

Products on ANDA 075095

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 075095

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/30/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75095ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/27/2012	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
08/22/2006	SUPPL-5	Labeling		Label is not available on this site.
02/01/2002	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
02/01/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075095

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

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