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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/06/1967 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016320s066lbl.pdf
10/30/2008 SUPPL-63 Labeling Label (PDF)
Letter (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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016320s063ltr.pdf
03/24/2004 SUPPL-60 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16320slr060_myambutol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16320slr060ltr.pdf
02/06/2003 SUPPL-58 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16320slr057_Myambutol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16320slr057,058ltr.pdf
02/06/2003 SUPPL-57 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16320slr057_Myambutol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16320slr057,058ltr.pdf
10/10/2001 SUPPL-56 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16320s56lbl.pdf
05/14/1998 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

05/08/1998 SUPPL-54 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/20/1995 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/1987 SUPPL-52 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/23/1987 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/1987 SUPPL-50 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/03/1986 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1985 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

06/25/1987 SUPPL-46 Labeling

Label is not available on this site.

02/24/1982 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1981 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

08/18/1981 SUPPL-42 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/18/1981 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1981 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1981 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

04/03/1979 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/1979 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

12/21/1978 SUPPL-36 Labeling

Label is not available on this site.

06/26/1978 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

06/27/1978 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1978 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

04/07/1978 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/1977 SUPPL-31 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/13/1977 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1976 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1976 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/1975 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

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

MYAMBUTOL

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 AKORN
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 AKORN
ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE 400MG TABLET;ORAL Prescription No AB 076057 BARR
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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