Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050406
Company: PRAGMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KEFLEX CEPHALEXIN EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** FOR SUSPENSION;ORAL Discontinued None Yes No
KEFLEX CEPHALEXIN EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons* FOR SUSPENSION;ORAL Discontinued None Yes No
KEFLEX CEPHALEXIN EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons* FOR SUSPENSION;ORAL Discontinued None Yes No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 Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/18/2018 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050406s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050406Orig1s013ltr.pdf
05/15/1996 SUPPL-12 Labeling

Label is not available on this site.

05/19/2009 SUPPL-11 Labeling

Label is not available on this site.

02/13/1995 SUPPL-10 Labeling

Label is not available on this site.

08/27/1992 SUPPL-8 Labeling

Label is not available on this site.

04/10/1990 SUPPL-7 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/18/2018 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050406s013lbl.pdf

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