Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050705
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RIFATER ISONIAZID; PYRAZINAMIDE; RIFAMPIN 50MG;300MG;120MG 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
05/31/1994 ORIG-1 Approval Type 4 - New Combination STANDARD; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2019 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050705s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050705Orig1s015ltr.pdf
01/23/2019 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050705s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050705Orig1s013ltr.pdf
01/08/2018 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050705s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050705Orig1s012ltr.pdf
04/24/2017 SUPPL-11 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/2017/050705s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050705Orig1s011ltr.pdf
02/27/2013 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050705s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050705Orig1s010ltr.pdf
11/12/2010 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050705s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050705s007ltr.pdf
12/18/2008 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050705s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050705s006ltr.pdf
04/28/2005 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050705s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050705s005ltr.pdf
10/06/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/12/2000 SUPPL-3 Labeling

Label is not available on this site.

04/08/1996 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/08/1994 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/28/2019 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050705s015lbl.pdf
01/23/2019 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050705s013lbl.pdf
01/08/2018 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050705s012lbl.pdf
04/24/2017 SUPPL-11 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/2017/050705s011lbl.pdf
02/27/2013 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050705s010lbl.pdf
11/12/2010 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050705s007lbl.pdf
12/18/2008 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050705s006lbl.pdf
04/28/2005 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050705s005lbl.pdf

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