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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062117
Company: FACTA FARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEPHALEXIN CEPHALEXIN EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* FOR SUSPENSION;ORAL Discontinued None No No
CEPHALEXIN CEPHALEXIN EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* FOR SUSPENSION;ORAL Discontinued None No No
CEPHALEXIN CEPHALEXIN EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* FOR SUSPENSION;ORAL Discontinued None No No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
03/27/1978 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/01/2000 SUPPL-34 Manufacturing (CMC)-Facility

Label is not available on this site.

06/01/1999 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

09/19/1996 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

08/06/1996 SUPPL-31 Labeling

Label is not available on this site.

03/01/1995 SUPPL-30 Labeling

Label is not available on this site.

06/23/1994 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

07/12/1996 SUPPL-28 Labeling

Label is not available on this site.

10/01/1993 SUPPL-27 Labeling

Label is not available on this site.

10/25/1993 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

06/30/1993 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/21/1993 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

11/24/1992 SUPPL-21 Labeling

Label is not available on this site.

02/07/1992 SUPPL-20 Labeling

Label is not available on this site.

02/28/1989 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

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