Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050429
Company: OXFORD PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RIMACTANE RIFAMPIN 300MG CAPSULE;ORAL Prescription AB 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
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
01/23/2019 SUPPL-86 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050429s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050429Orig1s086ltr.pdf
11/18/2004 SUPPL-83 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/2004/50429s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50429s083ltr.pdf
03/01/2001 SUPPL-81 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/26/2000 SUPPL-80 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/2000 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

02/18/1999 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

10/30/1998 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

08/14/1998 SUPPL-76 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1997 SUPPL-75 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1996 SUPPL-74 Manufacturing (CMC)-Control

Label is not available on this site.

03/27/1995 SUPPL-73 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/06/1994 SUPPL-72 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1994 SUPPL-71 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/23/1992 SUPPL-70 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1992 SUPPL-69 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1992 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1991 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1992 SUPPL-66 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/28/1982 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1982 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/1981 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1981 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

07/02/1980 SUPPL-61 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/29/1979 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1979 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1979 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

01/22/1979 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1978 SUPPL-55 Labeling

Label is not available on this site.

05/05/1978 SUPPL-53 Labeling

Label is not available on this site.

02/01/1978 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

09/27/1977 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

06/21/1977 SUPPL-50 Labeling

Label is not available on this site.

06/14/1977 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

06/01/1977 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

05/31/1977 SUPPL-47 Labeling

Label is not available on this site.

02/18/1977 SUPPL-46 Labeling

Label is not available on this site.

09/14/1976 SUPPL-45 Labeling

Label is not available on this site.

07/21/1976 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1976 SUPPL-43 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/18/1976 SUPPL-42 Efficacy-New Dosing Regimen

Label is not available on this site.

03/26/1976 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

12/09/1975 SUPPL-40 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/22/1975 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

12/09/1974 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/30/1974 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/18/1974 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/28/1974 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/24/1974 SUPPL-34 Labeling

Label is not available on this site.

01/16/1974 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/1973 SUPPL-32 Labeling

Label is not available on this site.

10/09/1973 SUPPL-31 Labeling

Label is not available on this site.

10/04/1973 SUPPL-30 Labeling

Label is not available on this site.

05/09/1973 SUPPL-29 Efficacy-New Dosing Regimen

Label is not available on this site.

10/26/1973 SUPPL-28 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/04/1973 SUPPL-27 Labeling

Label is not available on this site.

01/30/1973 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/05/1973 SUPPL-25 Labeling

Label is not available on this site.

10/03/1972 SUPPL-24 Labeling

Label is not available on this site.

08/10/1972 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

07/14/1972 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/29/1972 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

05/17/1972 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1972 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/22/1972 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

01/14/1972 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1971 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1971 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1971 SUPPL-14 Labeling

Label is not available on this site.

05/24/1971 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

02/23/1990 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1989 SUPPL-11 Labeling

Label is not available on this site.

11/29/1988 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1988 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1985 SUPPL-8 Labeling

Label is not available on this site.

07/08/1985 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1985 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/03/1985 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/25/1984 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1983 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1983 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1982 SUPPL-1 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
01/23/2019 SUPPL-86 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050429s086lbl.pdf
11/18/2004 SUPPL-83 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/2004/50429s083lbl.pdf

RIMACTANE

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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