Drugs@FDA: FDA-Approved Drugs
Company: PRAGMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KEFLEX | CEPHALEXIN | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| KEFLEX | CEPHALEXIN | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| KEFLEX | CEPHALEXIN | EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| KEFLEX | CEPHALEXIN | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 01/04/1971 | 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 |
|---|---|---|---|---|---|
| 09/06/2019 | SUPPL-110 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050405s110lbl.pdf | |
| 12/19/2018 | SUPPL-108 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050405s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050405Orig1s108Ltr.pdf | |
| 12/18/2018 | SUPPL-107 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050405s107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050405Orig1s107ltr.pdf | |
| 10/30/2015 | SUPPL-106 | 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/2015/050405s106lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050405Orig1s106ltr.pdf |
| 12/30/2013 | SUPPL-104 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/2008 | SUPPL-101 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050405s101ltr.pdf |
| 05/21/2008 | SUPPL-99 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050405s099ltr.pdf |
| 05/12/2006 | SUPPL-97 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050405s097lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050405s097ltr.pdf | |
| 06/25/2004 | SUPPL-95 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50405slr095ltr.pdf |
| 01/15/2004 | SUPPL-94 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50405slr094_keflex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50405slr094ltr.pdf | |
| 10/23/2002 | SUPPL-93 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/19/2004 | SUPPL-92 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50405s092ltr.pdf |
| 07/27/2001 | SUPPL-91 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/1996 | SUPPL-90 | Labeling |
Label is not available on this site. |
||
| 02/13/1995 | SUPPL-89 | Labeling |
Label is not available on this site. |
||
| 11/04/1988 | SUPPL-88 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1977 | SUPPL-87 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1977 | SUPPL-86 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/22/1977 | SUPPL-85 | Labeling |
Label is not available on this site. |
||
| 03/15/1977 | SUPPL-84 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/09/1977 | SUPPL-83 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/28/1977 | SUPPL-82 | Labeling |
Label is not available on this site. |
||
| 12/17/1976 | SUPPL-81 | Labeling |
Label is not available on this site. |
||
| 12/10/1976 | SUPPL-80 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/10/1976 | SUPPL-79 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/08/1976 | SUPPL-78 | Labeling |
Label is not available on this site. |
||
| 09/08/1976 | SUPPL-77 | Labeling |
Label is not available on this site. |
||
| 09/02/1976 | SUPPL-76 | Labeling |
Label is not available on this site. |
||
| 08/10/1976 | SUPPL-75 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/08/1976 | SUPPL-74 | Labeling |
Label is not available on this site. |
||
| 04/22/1976 | SUPPL-73 | Labeling |
Label is not available on this site. |
||
| 04/09/1976 | SUPPL-72 | Labeling |
Label is not available on this site. |
||
| 03/10/1976 | SUPPL-71 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/10/1976 | SUPPL-70 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/17/1975 | SUPPL-69 | Labeling |
Label is not available on this site. |
||
| 10/24/1975 | SUPPL-68 | Labeling |
Label is not available on this site. |
||
| 09/16/1975 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
| 09/08/1975 | SUPPL-64 | Labeling |
Label is not available on this site. |
||
| 09/04/1975 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 08/12/1975 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
| 08/04/1975 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 07/31/1975 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/08/1975 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 04/07/1975 | SUPPL-57 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/13/1974 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 10/02/1974 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 09/03/1974 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 10/04/1974 | SUPPL-53 | Efficacy-New Indication |
Label is not available on this site. |
||
| 08/28/1974 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 08/22/1974 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 08/16/1974 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 07/10/1974 | SUPPL-49 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/24/1974 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 06/28/1974 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 03/06/1974 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 02/20/1974 | SUPPL-45 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/24/1974 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/15/1974 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/1973 | SUPPL-42 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/02/1973 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 07/31/1973 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 07/25/1973 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/25/1973 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 06/19/1973 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 06/04/1973 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 04/27/1973 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 02/15/1973 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/18/1973 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/13/1972 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 07/19/1972 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/13/1972 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 02/24/1972 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 01/12/1972 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/13/1971 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/1971 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/06/1971 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 10/19/1971 | SUPPL-23 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 07/01/1971 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 05/19/1971 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 05/13/1971 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 04/14/1971 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 01/07/1971 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/09/1991 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/27/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 04/10/1990 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 09/21/1988 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 02/17/1987 | SUPPL-12 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/04/1987 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/04/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1986 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/06/1971 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/07/1971 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/21/1986 | SUPPL-5 | Efficacy-New Indication |
Label is not available on this site. |
||
| 11/22/1985 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/04/1985 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/1971 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/05/1984 | 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 |
|---|---|---|---|---|---|
| 09/06/2019 | SUPPL-110 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050405s110lbl.pdf | |
| 12/19/2018 | SUPPL-108 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050405s108lbl.pdf | |
| 12/18/2018 | SUPPL-107 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050405s107lbl.pdf | |
| 10/30/2015 | SUPPL-106 | 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/2015/050405s106lbl.pdf |
| 05/12/2006 | SUPPL-97 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050405s097lbl.pdf | |
| 01/15/2004 | SUPPL-94 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50405slr094_keflex_lbl.pdf |