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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 013026
Company: WYETH PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRECATOR ETHIONAMIDE 250MG TABLET;ORAL Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/30/1965 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
08/03/2023 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/013026s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/013026Orig1s032ltr.pdf
08/22/2016 SUPPL-29 Labeling-Package Insert 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/2016/013026s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/013026Orig1s029ltr.pdf
04/29/2014 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.
06/14/2006 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/013026s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/013026s024LTR.pdf
11/08/2004 SUPPL-23 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/13026s022,023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/13026s022,023ltr.pdf
11/08/2004 SUPPL-22 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/13026s022,023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/13026s022,023ltr.pdf
10/03/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
07/31/2001 SUPPL-20 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
11/12/1998 SUPPL-19 Manufacturing (CMC)-Formulation

Label is not available on this site.
10/05/1998 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
04/23/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
05/17/1994 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
03/18/1994 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
12/29/1992 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
04/26/1991 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
05/11/1990 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.
06/21/1989 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
03/10/1997 SUPPL-9 Labeling

Label is not available on this site.
05/31/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
06/04/1987 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/03/1987 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
10/26/1984 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.
04/01/1981 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
06/20/1974 SUPPL-3

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/03/2023 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/013026s032lbl.pdf
08/22/2016 SUPPL-29 Labeling-Package Insert 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/2016/013026s029lbl.pdf
06/14/2006 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/013026s024lbl.pdf
11/08/2004 SUPPL-23 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/13026s022,023lbl.pdf
11/08/2004 SUPPL-22 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/13026s022,023lbl.pdf
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