Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050420
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RIFADIN RIFAMPIN 300MG CAPSULE;ORAL Prescription AB 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
05/21/1971 ORIG-1 Approval UNKNOWN

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-80 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050420s080,050627s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050420Orig1s080, 050627Orig1s023ltr.pdf
01/23/2019 SUPPL-78 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050420s078,050627s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050420Orig1s078, 050627Orig1s021ltr.pdf
01/08/2018 SUPPL-77 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050420s077,050627s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050420Orig1s077, 050627Orig1s020ltr.pdf
04/24/2017 SUPPL-76 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/2017/050420s076,050627s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050627Orig1S017,050420Orig1S076ltr.pdf
02/27/2013 SUPPL-75 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050420s075,050627s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050420Orig1s075,050627Orig1s014ltr.pdf
11/10/2010 SUPPL-73 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050420s073,050627s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050420s073,050627s012ltr.pdf
08/20/2004 SUPPL-72 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50420s072,50627s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50420s072,50627s008ltr.pdf
04/12/2000 SUPPL-71 Labeling

Label is not available on this site.

04/12/2000 SUPPL-70 Labeling

Label is not available on this site.

09/05/1995 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

09/17/1996 SUPPL-67 Labeling

Label is not available on this site.

07/12/1994 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

01/05/1996 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1993 SUPPL-63 Labeling

Label is not available on this site.

10/20/1981 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

10/20/1981 SUPPL-60 Labeling

Label is not available on this site.

09/11/1982 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

12/31/1980 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1980 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1979 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

10/25/1979 SUPPL-55 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/25/1979 SUPPL-54 Labeling

Label is not available on this site.

05/01/1979 SUPPL-53 Labeling

Label is not available on this site.

04/16/1979 SUPPL-52 Labeling

Label is not available on this site.

04/16/1979 SUPPL-51 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/23/1979 SUPPL-50 Labeling

Label is not available on this site.

06/26/1979 SUPPL-49 Labeling

Label is not available on this site.

06/29/1978 SUPPL-48 Labeling

Label is not available on this site.

05/30/1978 SUPPL-47 Labeling

Label is not available on this site.

02/10/1978 SUPPL-46 Labeling

Label is not available on this site.

06/29/1977 SUPPL-45 Labeling

Label is not available on this site.

12/21/1976 SUPPL-44 Labeling

Label is not available on this site.

08/09/1976 SUPPL-43 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/03/1976 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1976 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/1976 SUPPL-40 Labeling

Label is not available on this site.

01/28/1976 SUPPL-39 Labeling

Label is not available on this site.

01/19/1976 SUPPL-38 Labeling

Label is not available on this site.

03/29/1976 SUPPL-37 Labeling

Label is not available on this site.

08/28/1975 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/15/1975 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/16/1975 SUPPL-34 Labeling

Label is not available on this site.

01/30/1975 SUPPL-33 Labeling

Label is not available on this site.

11/26/1974 SUPPL-32 Labeling

Label is not available on this site.

05/21/1974 SUPPL-31 Labeling

Label is not available on this site.

05/29/1974 SUPPL-30 Labeling

Label is not available on this site.

03/28/1974 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/28/1974 SUPPL-28 Labeling

Label is not available on this site.

01/24/1974 SUPPL-27 Labeling

Label is not available on this site.

10/11/1973 SUPPL-26 Labeling

Label is not available on this site.

11/20/1973 SUPPL-25 Labeling

Label is not available on this site.

05/09/1973 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1973 SUPPL-23 Labeling

Label is not available on this site.

10/05/1972 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/25/1972 SUPPL-21 Labeling

Label is not available on this site.

08/31/1972 SUPPL-20 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/16/1972 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/22/1982 SUPPL-18 Labeling

Label is not available on this site.

01/26/1972 SUPPL-17 Labeling

Label is not available on this site.

12/06/1971 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/1971 SUPPL-15 Labeling

Label is not available on this site.

11/16/1987 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1989 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1984 SUPPL-12 Labeling

Label is not available on this site.

02/18/1986 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/08/1984 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/12/1990 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

09/02/1983 SUPPL-8 Labeling

Label is not available on this site.

02/12/1990 SUPPL-7 Labeling

Label is not available on this site.

05/25/1977 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/17/1982 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/1982 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/1982 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1982 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/05/1982 SUPPL-1 Manufacturing (CMC)

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-80 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050420s080,050627s023lbl.pdf
01/23/2019 SUPPL-78 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050420s078,050627s021lbl.pdf
01/08/2018 SUPPL-77 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050420s077,050627s020lbl.pdf
04/24/2017 SUPPL-76 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/2017/050420s076,050627s017lbl.pdf
02/27/2013 SUPPL-75 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050420s075,050627s014lbl.pdf
11/10/2010 SUPPL-73 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050420s073,050627s012lbl.pdf
08/20/2004 SUPPL-72 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50420s072,50627s008lbl.pdf

RIFADIN

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RIFADIN RIFAMPIN 300MG CAPSULE;ORAL Prescription Yes AB 050420 SANOFI AVENTIS US
RIFAMPIN RIFAMPIN 300MG CAPSULE;ORAL Prescription No AB 065028 AKORN
RIFAMPIN RIFAMPIN 300MG CAPSULE;ORAL Prescription No AB 065390 LANNETT CO INC
RIFAMPIN RIFAMPIN 300MG CAPSULE;ORAL Prescription No AB 090034 LUPIN PHARMS
RIFAMPIN RIFAMPIN 300MG CAPSULE;ORAL Prescription No AB 064150 SANDOZ
RIMACTANE RIFAMPIN 300MG CAPSULE;ORAL Prescription No AB 050429 OXFORD PHARMS

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