Drugs@FDA: FDA-Approved Drugs
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 |
|---|---|---|---|---|---|
| 08/16/2023 | SUPPL-87 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050429s087lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050429Orig1s087ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 08/16/2023 | SUPPL-87 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050429s087lbl.pdf | |
| 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 |
|---|---|---|---|---|---|---|---|---|
| RIFAMPIN | RIFAMPIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 065390 | CHARTWELL MOLECULAR |
| RIFAMPIN | RIFAMPIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 064150 | EPIC PHARMA LLC |
| RIFAMPIN | RIFAMPIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 090034 | LUPIN PHARMS |
| RIMACTANE | RIFAMPIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 050429 | OXFORD PHARMS |