Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016320
Company: STI PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYAMBUTOL ETHAMBUTOL HYDROCHLORIDE 100MG TABLET;ORAL Prescription AB Yes No
MYAMBUTOL ETHAMBUTOL HYDROCHLORIDE 200MG TABLET;ORAL Discontinued None No No
MYAMBUTOL ETHAMBUTOL HYDROCHLORIDE 400MG TABLET;ORAL Prescription AB Yes Yes
MYAMBUTOL ETHAMBUTOL HYDROCHLORIDE 500MG TABLET;ORAL Discontinued None No No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/22/2013 SUPPL-66 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016320s066lbl.pdf
10/30/2008 SUPPL-63 Labeling Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016320s063lbl.pdf
03/24/2004 SUPPL-60 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16320slr060_myambutol_lbl.pdf
02/06/2003 SUPPL-58 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16320slr057_Myambutol_lbl.pdf
02/06/2003 SUPPL-57 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16320slr057_Myambutol_lbl.pdf
10/10/2001 SUPPL-56 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16320s56lbl.pdf

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