APPLICATION
ANDA075095
TYPE
ANDA
ORIGINAL APPROVAL
1999-11-30
LATEST ACTION
2012-01-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ETHAMBUTOL HYDROCHLORIDEPrescription
ETHAMBUTOL HYDROCHLORIDE 400MG · TABLET · ORAL
ETHAMBUTOL HYDROCHLORIDEPrescription
ETHAMBUTOL HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2012-01-27Labeling · Supplement 6AP
2006-08-22Labeling · Supplement 5AP
2002-02-01Manufacturing (CMC) · Supplement 1AP
2002-02-01Manufacturing (CMC) · Supplement 2AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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