Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050405
Company: PRAGMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KEFLEX CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription AB Yes No
KEFLEX CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription AB Yes No
KEFLEX CEPHALEXIN EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
KEFLEX CEPHALEXIN EQ 750MG BASE 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
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
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
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

KEFLEX

CAPSULE;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription No AB 090836 ALKEM LABS LTD
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription No AB 065253 AUROBINDO PHARMA LTD
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription No AB 062713 BELCHER PHARMS
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription No AB 065215 HIKMA
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription No AB 065229 LUPIN
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription No AB 065248 ORCHID HLTHCARE
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription No AB 062791 SUN PHARM INDS (IN)
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription No AB 062702 TEVA
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription No AB 065152 YUNG SHIN PHARM
KEFLEX CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Prescription Yes AB 050405 PRAGMA

CAPSULE;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription No AB 090836 ALKEM LABS LTD
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription No AB 065253 AUROBINDO PHARMA LTD
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription No AB 062713 BELCHER PHARMS
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription No AB 065215 HIKMA
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription No AB 065229 LUPIN
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription No AB 065248 ORCHID HLTHCARE
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription No AB 062791 SUN PHARM INDS (IN)
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription No AB 062702 TEVA
CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription No AB 065152 YUNG SHIN PHARM
KEFLEX CEPHALEXIN EQ 500MG BASE CAPSULE;ORAL Prescription Yes AB 050405 PRAGMA

CAPSULE;ORAL; EQ 750MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEPHALEXIN CEPHALEXIN EQ 750MG BASE CAPSULE;ORAL Prescription No AB 090836 ALKEM LABS LTD
KEFLEX CEPHALEXIN EQ 750MG BASE CAPSULE;ORAL Prescription Yes AB 050405 PRAGMA

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English