Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062206
Company: FACTA FARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFACLOR CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION;ORAL Discontinued None No No
CEFACLOR CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Discontinued None No No
CEFACLOR CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION;ORAL Discontinued None No No
CEFACLOR CEFACLOR EQ 375MG BASE/5ML 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
04/23/1979 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
03/27/2000 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/2000 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/2000 SUPPL-50 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/20/1999 SUPPL-49 Manufacturing (CMC)-Facility

Label is not available on this site.

08/30/1999 SUPPL-48 Labeling

Label is not available on this site.

10/23/1997 SUPPL-47 Labeling

Label is not available on this site.

09/30/1998 SUPPL-46 Labeling

Label is not available on this site.

11/13/1996 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

04/01/1997 SUPPL-43 Labeling

Label is not available on this site.

05/10/1996 SUPPL-40 Labeling

Label is not available on this site.

06/10/1996 SUPPL-38 Labeling

Label is not available on this site.

06/23/1994 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

04/27/1993 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

04/27/1993 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

06/02/1994 SUPPL-34 Labeling

Label is not available on this site.

07/13/1994 SUPPL-33 Labeling

Label is not available on this site.

01/07/1993 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

05/24/1994 SUPPL-29 Labeling

Label is not available on this site.

08/31/1992 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/12/1991 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/26/1989 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/20/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

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